%22%2F%3E%0A%3Cdefs%3E%0A%3Cpattern%20id%3D%22pattern0%22%20patternContentUnits%3D%22objectBoundingBox%22%20width%3D%221%22%20height%3D%221%22%3E%0A%3Cuse%20xlink%3Ahref%3D%22%23image0_10319_58637%22%20transform%3D%22scale(0.00350877%200.0142857)%22%2F%3E%0A%3C%2Fpattern%3E%0A%3Cimage%20id%3D%22image0_10319_58637%22%20width%3D%22285%22%20height%3D%2270%22%20xlink%3Ahref%3D%22data%3Aimage%2Fpng%3Bbase64%2CiVBORw0KGgoAAAANSUhEUgAAAR0AAABGCAYAAADxVED7AAAAAXNSR0IArs4c6QAAE2xJREFUeF7tXY3xJUUR38nAIwHFBBQTQEhAMAE5E1BMQDABIAG9iwCMgCMCIQGBCCCDsX7r9FZvb%2Fd0z%2B68938cvVVXd3Vvdz56en7T31OWfJICSYGfNQVqrb8FAUopX9%2BDEOUenWQfSYGkwGNRoNb6i2VZ%2FrIsy1%2BXZcG%2F8fy4LMunpZSPbznaBJ1bUjfbTgo8IAVqrQCbjxjYyFG%2BKKU8v9XQE3RuRdlsNynwYBRo0s0ny7J8EBjaB6WUl4H3hl9J0BkmWX6QFPjpUaDW%2BqtlWb5clgV%2FR56vSylvRV4cfSdBZ5Ri%2BX5S4CdGgROAQzN8p5TyavZ0E3RmUzTbSwo8EAUuAA5m8VkpBYbmqU%2BCzlRyZmNJgcehwEXAwURelVLemT2jBJ3ZFM32kgIPQIEJgINZ%2FFhKeTZ7Ogk6syma7SUFnpgCkwCHZvFmKeW7mVNK0JlJzWwrKfDEFJgMOJjN81LKi5nTStCZSc1sKynwhBRocTj%2FGXCLR0b7YSnl08iL0XcSdKKUyveSAg9OgVorAGfNowo8ny3LAgnmcwekpkcnJ%2BgEVidfSQo8OgVqrYg0jrq3N%2Bml1opv8K31%2FLuU8t7M%2BSfozKRmtpUUeAIK1Fr%2F3nKpvN6R0AnA2Ww0tVYACqQd65kemZyg4y1T%2Fp4UeGAKtOTNqM3lLVm%2Bohmev%2B1M8btSypszSZCgM5Oa2VZS4I4UqLX%2BvuVTRXo1vVC11tppYHqsToJOZLnynaTAg1Fg0DXedXvXWiHpmImgpZSpODG1sQdblxxOUuC1pMBMwAGBaq3IPofUpD4JOq8lG%2BWkkgJxCgy4xkOBfbVWGJb%2F1BnB1KjklHTia51vJgWenAIDnqoQ4DRJB1UE4QGzngSdJ1%2F5HEBS4Ako4HiqIK1slf5G6uAEYnUSdJ5gvbPLpMCTUqDd2ICIY%2B1BIfUflLrHuN0BsTnfLMuCb7%2FXwKjWivKl%2F%2BpM8OBqv0KMVK%2BuUC%2B%2FTQrcgQIBwzHKilqApI0QYPQV6uUsy0LABBXrN4ZBeWoFwQSdOzBNdpEUuEIBz7u0LAuC93oBfl73KF0BAMIfSEVwnyNS%2Be327wQdj4L5e1LgdaFA0HCMQlsAHbq%2FCvlU%2BBMtwi7JRZLQF%2B0HRCVPq6mTks7rwp05j9eOAoEUBcx59VLVWpEKgfus8Kw2mBaxDHtNzx3u0Y2kICR%2BEgh533R%2FT9C5RL78OClwGwoEa%2BNsbnGREvFxKQU2mvVp4IXgP7jFz0o%2FaApGaQDPJQBK0LkNz2SrSYFLFAiUqjjE4TDbD8ABbm78vXsmST8cgF6OuOfxYYLOJdbIj5MC8ynguMc3lUoBFEgxZFDeSTvGu6R6XZF%2B0DSpYLiyBvagVK88IuTvSYFHokAnAfNQD0cBE7Lt4F3YdlwDcIvTgd3HzL8aoA9c9wAf80rilHQGqJmvJgVuTYFOoB5ABK7rriQhbEFflFLej4y52X3wKmxBVwzP1B0kLkhbB%2FBJ0ImsSL6TFLgTBQwpJwQ4NERRDTAUY1NrJbBZDcVN6gH4XFW9kMH%2BZy5xJejciZmym6SARwGjKNcQ4DDgQQlSBPhBvYKadTAq8%2FEoEhZyuVC8HYXe4YqPFnzXpgmp510CngQdjxPy96TAnSjQpA2Z7d01CFtDG1WzOmrderVwA0SAz9ki7RvwJOjciaGym6SARwGjSPqnpZQPvW%2B134Xk1L2%2FqlP6dFcjudl%2Bztp9viylvJugc2Y185ukwI0oYORZfVRKQSb58MMilbverI6bfpV0ZMcNpJCZPmLzQS3mNxJ0hpcxP0gK3JYChpoF2wyMwq4LXAEIKkdq2nc6KRdwf6v3adVagR8Anqi3C6Dzu2HQaciJFHh6IH49v%2B0yjLfedFoQ45vRiMnx3q5%2F0cbbu3%2FobCeo5h9ym57tIL%2BbT4GOGgMDL%2Bw8YfARpTFUN3oHdDy1DBnu%2Fw1SYBx0OgN75lnHg4O6%2FFobI8AG6Iys23DZxsudX2ggmNx3pofp9xadGUR%2Bc44CHfAZUrma%2BgSJB3vi8G2H%2F0yXe5N0%2FrksCyKbI8%2B3pZRfD0k6nbKGpyzskVGOvqMUmU7QmXxZ2uia5PvXKWCAD6QdAIgZ%2Fct7Fh6qHfCMChRMMh%2BJYl5xYhR0rPtxVGPTdVKPt5Cgc6BZSjrjbPSwX3TAB4crinB1H2Ev2oDH8F6pVwqfNCKvUg4GFwadwG2CochHjyhXf%2F%2Bpgs7VeeP7xpDIfaFiTvjvh5FCZ8wx2%2Fg%2FBQzwCdl7BPBAWoKk9AclAHBnz2nSDeKIVMNyZ23OBQcqmxk5IDxK8SGY%2B%2BcKOkb9lYeRQBMsbkOBs%2BBjeMjkILdbIE5KN2hvBzhhSacxNKrN80fWZb1853EjIPz%2B%2BIO4AvyBiNcN4RZ6q7w47G42nTZ%2BADFJGuscImLvVZZUwHbYxdqMjaA9xo%2Fvp5apvDpH%2Bb2gN8YLWrulFbxxNH4HHehQPcWL1I%2FSHn5Cm6Dv5fEakg%2Fo8aIX3%2BMAySpEXJBuVMAZAR15RQUm81wJZBpWsdrEEVoNjxNXCzhvYGEQmXkwmLWNwkOzpZiIBDYUm6YHILaVXWzGcd4v%2BtlAro0PY1vBpAijbFsUhIeTt0zjaaq4NuTq9DYHY2r0j5IG%2FAmtBZsfaKjRfzVWtmpxKvi3zc89GBuNWegC2peADBsEXLghQyjbXNw7KclEtV2Gad1oAfWhZxzFmMH%2F7pgbXcAXPd7GeLF2qMYXdoNbvKFIPq6xmZW2ANASWL1s92xh7a192WNRHP5Qzw48E7LpWOCieLNWMBrYLJ8M6oeH0ztwZ48czm6MSlbvKlJapwC%2F17kBHmJrRqIyzcWI0k1IdrxwE%2F3kqroNDBDYFc2lAe3f105mxd5HhxI2byRqNWqLALiObIKQW7ltVIxzxBPTlSRPbFi0h0A8eXicYQvN5uOCDzvEqLTpCD3oc2hE%2F%2BjNwwUdxZW2eUMa4%2FIq9GaZREU01gCHJAK8DnTFySg39C7r9hag006mrcYsHzuBTucuIpyEdGJZc5hiazHG4LbdGTskShL3QXeN6T6Qp7wGOq08wkiwYzcbutYKUJDxICTVYIlIHZKnchd4nHWEhEwnNQJiJUCrGeDGDQ54F7xB7Vn07QbjjSKQAqhYX%2FRx8HRdVKUwtEMZC228EdCRNhIpKVCINbXv2lAUoMBC4LtDtfn2LgCKM9PGoC1JjqrgE%2FNxoFptE2zyEOeRsr8%2BiqSD6F1zszDQkeEDWExIAgcR2YhvOmzeEwxF5Qvo05AdR5mzyoiGkfKQw6OADhhaU6XwrQXEmIOa3KjUC8Y8VRexYSBVaW0ATq9t8BVozh0oO3oY8S7gN4DfTtVo74K3OZiFD%2B4RflEk9510eUIy49270s3u4PYGbqkfbNNKe0%2FkpJVA1d2AwhWMDYIiQzvbCxvPkCFZmR9tDDRJfeFvMlSuoCJKPHZP6fa%2BvKRejYHw1oPNE7YHKY25dhzlFMbc8J1prFc28m6NO%2BEUaBMb7rBWHSPmbg7KAeUCq3GoHQqVnzG%2BN2kA%2FEvAA4CF5LBKiI1X%2Bc0LrslBMV%2B46nGUTxQNA%2FuVboVY16apwGdUqbB0EwYdJdX%2BsFEUFQvtd9Miaq3IwaAn5PVqY3E9QaMu80492pCYSx4U704gg06nLqY3MoJdRjVO4dAYaq2I%2F%2BEn%2FAYOZ4tPGZLGLsFQWZ%2BQhKjwgXYti7wVM0oLbFD8UQ8%2BdjBAgsGe6RqIlX3mHtxnQYeNDWsJp0vPAdLrBgcKaDpsg%2BqqV8rCWWKqlC68SvTDoBMl8iTQCQFOdExsoaWE914pBVJb%2BDlrx2mnMBgM4jw97inMxm5%2Ba4BOiIaK6gkvzqpuKO2Go6u9bxU%2BuflGtxZZCUkJHcRhphEvtkMLNrKz1QAh3UG9PeVtM0Fn5FTUdHqtBgdjYOiA3EYT8jJEiDwBdG7GfKNj0%2BariOKuusHoLqWVMOgp%2FLBtDG%2BD99ZNaXeTpsWtlWjGLLNg0Era3Xiwm%2FwtJEFFePDMO0L6X7iX9Ex7HYAb9QDypkzb68gYe6AjbTXbCWQssASSXnaqPPHR5FqT9Wqw1OjGPiu%2BjxCZbfohe5Psw%2FCKuHacJjUA5GWA51B1gFqrXGMeXoA1pafLK8q8uOTLvaOST0JzZfSWhna6ghcnPACYPyHV6sy6R76RfDgbdE6GBfChq8bwyNzkOz3QGToJRk4lJ4%2BLLm9fXc%2BjIDQBdNZ7oM8QU9lMFN1Lf8u7hVxPH9tAUDmkV82147Dv5UbDqTVaZ0fG3KySkhWnE6WhOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination with Itraconazole in Healthy Participants
Study identifier:D6970C00005
ClinicalTrials.gov identifier:NCT06357520
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of baxdrostat when administered alone and in combination with itraconazole
Medical condition
Healthy Participants
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Itraconazole, Baxdrostat
Sex
All
Actual Enrollment
14
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 16 Apr 2024
Primary Completion Date: 17 Jun 2024
Study Completion Date: 17 Jun 2024
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other
Verification:
Verified 01 Jan 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Brooklyn, MD, United States, 21225
| Arms | Assigned Interventions |
|---|---|
| Experimental: Baxdrostat and Itraconazole Participants will receive single dose of baxdrostat tablet orally on Day 1 in Period 1, followed by itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8 in Period 2, and then single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16 in Period 3. | Drug: Baxdrostat Baxdrostat tablet will be administered orally. Other Name: CIN-107 |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| The study was conducted from 16 April 2024 to 06 June 2024 in a single country. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. |
Reporting Groups
| Description | |
|---|---|
| Baxdrostat/Baxdrostat+Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 1 in Period 1, followed by itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8 in Period 2, and then single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16 in Period 3. |
Participant Flow: Overall Study
| Baxdrostat/Baxdrostat+Itraconazole | |
|---|---|
| STARTED | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
The safety analysis set included all participants who received at least one dose of baxdrostat and for whom any safety post-dose data were available.
Reporting Groups
| Description | |
|---|---|
| Baxdrostat/Baxdrostat+Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 1 in Period 1, followed by itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8 in Period 2, and then single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16 in Period 3. |
Baseline Measures
| Baxdrostat/Baxdrostat+Itraconazole | |
|---|---|
|
Number of Participants
[units: Participants] |
14 |
| Age Continuous [units: Years] Mean ± Standard Deviation |
37.4 ± 6.5 |
| Sex: Female, Male [units: Participants] |
|
| Female | 0 |
| Male | 14 |
| Race/Ethnicity, Customized [units: Participants] Race
|
|
| Black or African American | 3 |
| White | 10 |
| Other | 1 |
Outcome Measures
1. Primary Outcome Measure: Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) |
| Measure Description | The effect of itraconazole on the pharmacokinetic (PK) parameter, AUCinf of baxdrostat was assessed. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) [units: Hours*nanogram per milliliter (h*ng/mL)] Geometric Mean (Geometric Coefficient of Variation) |
711.1 (31.99%) | 1108 (25.83%) |
No statistical analysis provided for Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf)
2. Primary Outcome Measure: Maximum Observed Plasma Drug Concentration (Cmax) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Primary |
|---|---|
| Measure Name | Maximum Observed Plasma Drug Concentration (Cmax) |
| Measure Description | The effect of itraconazole on the PK parameter, Cmax of baxdrostat was assessed. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Maximum Observed Plasma Drug Concentration (Cmax) [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation) |
19.03 (5.357%) | 24.65 (16.28%) |
No statistical analysis provided for Maximum Observed Plasma Drug Concentration (Cmax)
3. Secondary Outcome Measure: Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) |
| Measure Description | The PK parameter, AUClast of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation) |
657.8 (27.38%) | 1058 (23.23%) |
No statistical analysis provided for Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
4. Secondary Outcome Measure: Apparent Total Body Clearance (CL/F) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Apparent Total Body Clearance (CL/F) |
| Measure Description | The PK parameter, CL/F of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Apparent Total Body Clearance (CL/F) [units: Litres/hour (L/h)] Geometric Mean (Geometric Coefficient of Variation) |
2.813 (31.99%) | 1.805 (25.83%) |
No statistical analysis provided for Apparent Total Body Clearance (CL/F)
5. Secondary Outcome Measure: Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F) |
| Measure Description | The PK parameter, Vz/F of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F) [units: Litre] Geometric Mean (Geometric Coefficient of Variation) |
120.2 (12.39%) | 105.2 (11.69%) |
No statistical analysis provided for Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F)
6. Secondary Outcome Measure: Terminal Elimination Half-life (t1/2λz) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Terminal Elimination Half-life (t1/2λz) |
| Measure Description | The PK parameter, t1/2λz of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Terminal Elimination Half-life (t1/2λz) [units: Hour] Geometric Mean (Geometric Coefficient of Variation) |
29.62 (26.86%) | 40.39 (22.36%) |
No statistical analysis provided for Terminal Elimination Half-life (t1/2λz)
7. Secondary Outcome Measure: Mean Residence Time (MRTinf) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Mean Residence Time (MRTinf) |
| Measure Description | The PK parameter, MRTinf of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Mean Residence Time (MRTinf) [units: Hour] Geometric Mean (Geometric Coefficient of Variation) |
43.25 (28.51%) | 57.01 (25.45%) |
No statistical analysis provided for Mean Residence Time (MRTinf)
8. Secondary Outcome Measure: Time To Reach Maximum Observed Concentration (tmax) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time To Reach Maximum Observed Concentration (tmax) |
| Measure Description | The PK parameter, tmax of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 |
| Time To Reach Maximum Observed Concentration (tmax) [units: Hour] Median (Full Range) |
2.50 (1.00 to 5.00) | 2.50 (0.50 to 4.00) |
No statistical analysis provided for Time To Reach Maximum Observed Concentration (tmax)
9. Secondary Outcome Measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax) |
| Measure Description | The PK parameter, RCmax of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 3: Baxdrostat + Itraconazole | |
|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 |
| Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax) [units: Ratio] Geometric Mean (Geometric Coefficient of Variation) |
1.295 (15.50%) |
No statistical analysis provided for Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax)
10. Secondary Outcome Measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast) |
| Measure Description | The PK parameter, RAUClast of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 3: Baxdrostat + Itraconazole | |
|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 |
| Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast) [units: Ratio] Geometric Mean (Geometric Coefficient of Variation) |
1.609 (11.86%) |
No statistical analysis provided for Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast)
11. Secondary Outcome Measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf) [ Time Frame: Period 1: Days 1 to 6 and Period 3: Days 9 to 17 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf) |
| Measure Description | The PK parameter, RAUCinf of baxdrostat when baxdrostat was administered alone or in combination with itraconazole was evaluated. |
| Time Frame | Period 1: Days 1 to 6 and Period 3: Days 9 to 17 |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The PK analysis set included all participants who received at least one dose of baxdrostat and had at least one evaluable PK concentration post dose without any protocol deviation which might had impacted baxdrostat plasma exposure. |
Reporting Groups
| Description | |
|---|---|
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 3: Baxdrostat + Itraconazole | |
|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 |
| Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf) [units: Ratio] Geometric Mean (Geometric Coefficient of Variation) |
1.558 (13.77%) |
No statistical analysis provided for Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf)
12. Secondary Outcome Measure: Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 8 weeks ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Number of Participants with Adverse Events (AEs) |
| Measure Description | The safety and tolerability of baxdrostat alone and in combination with itraconazole were assessed. |
| Time Frame | Approximately 8 weeks |
| Safety Issue? |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The safety analysis included all participants who received at least one dose of baxdrostat and for whom any safety post-dose data are available. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat Alone | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 2: Itraconazole | Participants received itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Measured Values
| Period 1: Baxdrostat Alone | Period 2: Itraconazole | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
14 | 14 | 14 |
| Number of Participants with Adverse Events (AEs) [units: Participants] |
|||
| Any AE | 0 | 1 | 1 |
| Any Serious Adverse Event (SAE) | 0 | 0 | 0 |
| Any SAE with outcome death | 0 | 0 | 0 |
| Any AE leading to discontinuation of study intervention | 0 | 0 | 0 |
| Any possibly related AE | 0 | 0 | 0 |
| Any possibly related SAE | 0 | 0 | 0 |
No statistical analysis provided for Number of Participants with Adverse Events (AEs)
Serious Adverse Events
| Time Frame | Approximately 8 weeks |
|---|---|
| Additional Description | The safety analysis included all participants who received at least one dose of baxdrostat and for whom any safety post-dose data are available. |
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 2: Itraconazole | Participants received itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Serious Adverse Events
| Period 1: Baxdrostat | Period 2: Itraconazole | Period 3: Baxdrostat + Itraconazole | |
|---|---|---|---|
| Total, serious adverse events | |||
| # participants affected / at risk | 0/14 (0.00%) | 0/14 (0.00%) | 0/14 (0.00%) |
Other Adverse Events
| Time Frame | Approximately 8 weeks |
|---|---|
| Additional Description | The safety analysis included all participants who received at least one dose of baxdrostat and for whom any safety post-dose data are available. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Period 1: Baxdrostat | Participants received single dose of baxdrostat tablet orally on Day 1. |
| Period 2: Itraconazole | Participants received itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8. |
| Period 3: Baxdrostat + Itraconazole | Participants received single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16. |
Other Adverse Events
| Period 1: Baxdrostat | Period 2: Itraconazole | Period 3: Baxdrostat + Itraconazole | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/14 (0.00%) | 1/14 (7.14%) | 1/14 (7.14%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Blood and lymphatic system disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lymphadenopathy1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/14 (0.00%) | 0/14 (0.00%) | 1/14 (7.14%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 0 | 0 | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Gastrointestinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abdominal pain upper1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/14 (0.00%) | 1/14 (7.14%) | 0/14 (0.00%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 0 | 1 | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| General disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fatigue1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/14 (0.00%) | 0/14 (0.00%) | 1/14 (7.14%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 0 | 0 | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Certain Agreements
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact
| Name/Title: | Global Clinical Lead |
| Organization: | AstraZeneca |
| Phone | 1-877-240-9479 |
| E-mail: | [email protected] |
Contacts
Contact
AstraZeneca Clinical Study Information Center
%22%2F%3E%0A%3Cdefs%3E%0A%3Cpattern%20id%3D%22pattern0%22%20patternContentUnits%3D%22objectBoundingBox%22%20width%3D%221%22%20height%3D%221%22%3E%0A%3Cuse%20xlink%3Ahref%3D%22%23image0_8556_33445%22%20transform%3D%22translate(0%200.0591543)%20scale(0.00350877%200.0125956)%22%2F%3E%0A%3C%2Fpattern%3E%0A%3Cimage%20id%3D%22image0_8556_33445%22%20width%3D%22285%22%20height%3D%2270%22%20xlink%3Ahref%3D%22data%3Aimage%2Fpng%3Bbase64%2CiVBORw0KGgoAAAANSUhEUgAAAR0AAABGCAYAAADxVED7AAAAAXNSR0IArs4c6QAAE2xJREFUeF7tXY3xJUUR38nAIwHFBBQTQEhAMAE5E1BMQDABIAG9iwCMgCMCIQGBCCCDsX7r9FZvb%2Fd0z%2B68938cvVVXd3Vvdz56en7T31OWfJICSYGfNQVqrb8FAUopX9%2BDEOUenWQfSYGkwGNRoNb6i2VZ%2FrIsy1%2BXZcG%2F8fy4LMunpZSPbznaBJ1bUjfbTgo8IAVqrQCbjxjYyFG%2BKKU8v9XQE3RuRdlsNynwYBRo0s0ny7J8EBjaB6WUl4H3hl9J0BkmWX6QFPjpUaDW%2BqtlWb5clgV%2FR56vSylvRV4cfSdBZ5Ri%2BX5S4CdGgROAQzN8p5TyavZ0E3RmUzTbSwo8EAUuAA5m8VkpBYbmqU%2BCzlRyZmNJgcehwEXAwURelVLemT2jBJ3ZFM32kgIPQIEJgINZ%2FFhKeTZ7Ogk6syma7SUFnpgCkwCHZvFmKeW7mVNK0JlJzWwrKfDEFJgMOJjN81LKi5nTStCZSc1sKynwhBRocTj%2FGXCLR0b7YSnl08iL0XcSdKKUyveSAg9OgVorAGfNowo8ny3LAgnmcwekpkcnJ%2BgEVidfSQo8OgVqrYg0jrq3N%2Bml1opv8K31%2FLuU8t7M%2BSfozKRmtpUUeAIK1Fr%2F3nKpvN6R0AnA2Ww0tVYACqQd65kemZyg4y1T%2Fp4UeGAKtOTNqM3lLVm%2Bohmev%2B1M8btSypszSZCgM5Oa2VZS4I4UqLX%2BvuVTRXo1vVC11tppYHqsToJOZLnynaTAg1Fg0DXedXvXWiHpmImgpZSpODG1sQdblxxOUuC1pMBMwAGBaq3IPofUpD4JOq8lG%2BWkkgJxCgy4xkOBfbVWGJb%2F1BnB1KjklHTia51vJgWenAIDnqoQ4DRJB1UE4QGzngSdJ1%2F5HEBS4Ako4HiqIK1slf5G6uAEYnUSdJ5gvbPLpMCTUqDd2ICIY%2B1BIfUflLrHuN0BsTnfLMuCb7%2FXwKjWivKl%2F%2BpM8OBqv0KMVK%2BuUC%2B%2FTQrcgQIBwzHKilqApI0QYPQV6uUsy0LABBXrN4ZBeWoFwQSdOzBNdpEUuEIBz7u0LAuC93oBfl73KF0BAMIfSEVwnyNS%2Be327wQdj4L5e1LgdaFA0HCMQlsAHbq%2FCvlU%2BBMtwi7JRZLQF%2B0HRCVPq6mTks7rwp05j9eOAoEUBcx59VLVWpEKgfus8Kw2mBaxDHtNzx3u0Y2kICR%2BEgh533R%2FT9C5RL78OClwGwoEa%2BNsbnGREvFxKQU2mvVp4IXgP7jFz0o%2FaApGaQDPJQBK0LkNz2SrSYFLFAiUqjjE4TDbD8ABbm78vXsmST8cgF6OuOfxYYLOJdbIj5MC8ynguMc3lUoBFEgxZFDeSTvGu6R6XZF%2B0DSpYLiyBvagVK88IuTvSYFHokAnAfNQD0cBE7Lt4F3YdlwDcIvTgd3HzL8aoA9c9wAf80rilHQGqJmvJgVuTYFOoB5ABK7rriQhbEFflFLej4y52X3wKmxBVwzP1B0kLkhbB%2FBJ0ImsSL6TFLgTBQwpJwQ4NERRDTAUY1NrJbBZDcVN6gH4XFW9kMH%2BZy5xJejciZmym6SARwGjKNcQ4DDgQQlSBPhBvYKadTAq8%2FEoEhZyuVC8HYXe4YqPFnzXpgmp510CngQdjxPy96TAnSjQpA2Z7d01CFtDG1WzOmrderVwA0SAz9ki7RvwJOjciaGym6SARwGjSPqnpZQPvW%2B134Xk1L2%2FqlP6dFcjudl%2Bztp9viylvJugc2Y185ukwI0oYORZfVRKQSb58MMilbverI6bfpV0ZMcNpJCZPmLzQS3mNxJ0hpcxP0gK3JYChpoF2wyMwq4LXAEIKkdq2nc6KRdwf6v3adVagR8Anqi3C6Dzu2HQaciJFHh6IH49v%2B0yjLfedFoQ45vRiMnx3q5%2F0cbbu3%2FobCeo5h9ym57tIL%2BbT4GOGgMDL%2Bw8YfARpTFUN3oHdDy1DBnu%2Fw1SYBx0OgN75lnHg4O6%2FFobI8AG6Iys23DZxsudX2ggmNx3pofp9xadGUR%2Bc44CHfAZUrma%2BgSJB3vi8G2H%2F0yXe5N0%2FrksCyKbI8%2B3pZRfD0k6nbKGpyzskVGOvqMUmU7QmXxZ2uia5PvXKWCAD6QdAIgZ%2Fct7Fh6qHfCMChRMMh%2BJYl5xYhR0rPtxVGPTdVKPt5Cgc6BZSjrjbPSwX3TAB4crinB1H2Ev2oDH8F6pVwqfNCKvUg4GFwadwG2CochHjyhXf%2F%2Bpgs7VeeP7xpDIfaFiTvjvh5FCZ8wx2%2Fg%2FBQzwCdl7BPBAWoKk9AclAHBnz2nSDeKIVMNyZ23OBQcqmxk5IDxK8SGY%2B%2BcKOkb9lYeRQBMsbkOBs%2BBjeMjkILdbIE5KN2hvBzhhSacxNKrN80fWZb1853EjIPz%2B%2BIO4AvyBiNcN4RZ6q7w47G42nTZ%2BADFJGuscImLvVZZUwHbYxdqMjaA9xo%2Fvp5apvDpH%2Bb2gN8YLWrulFbxxNH4HHehQPcWL1I%2FSHn5Cm6Dv5fEakg%2Fo8aIX3%2BMAySpEXJBuVMAZAR15RQUm81wJZBpWsdrEEVoNjxNXCzhvYGEQmXkwmLWNwkOzpZiIBDYUm6YHILaVXWzGcd4v%2BtlAro0PY1vBpAijbFsUhIeTt0zjaaq4NuTq9DYHY2r0j5IG%2FAmtBZsfaKjRfzVWtmpxKvi3zc89GBuNWegC2peADBsEXLghQyjbXNw7KclEtV2Gad1oAfWhZxzFmMH%2F7pgbXcAXPd7GeLF2qMYXdoNbvKFIPq6xmZW2ANASWL1s92xh7a192WNRHP5Qzw48E7LpWOCieLNWMBrYLJ8M6oeH0ztwZ48czm6MSlbvKlJapwC%2F17kBHmJrRqIyzcWI0k1IdrxwE%2F3kqroNDBDYFc2lAe3f105mxd5HhxI2byRqNWqLALiObIKQW7ltVIxzxBPTlSRPbFi0h0A8eXicYQvN5uOCDzvEqLTpCD3oc2hE%2F%2BjNwwUdxZW2eUMa4%2FIq9GaZREU01gCHJAK8DnTFySg39C7r9hag006mrcYsHzuBTucuIpyEdGJZc5hiazHG4LbdGTskShL3QXeN6T6Qp7wGOq08wkiwYzcbutYKUJDxICTVYIlIHZKnchd4nHWEhEwnNQJiJUCrGeDGDQ54F7xB7Vn07QbjjSKQAqhYX%2FRx8HRdVKUwtEMZC228EdCRNhIpKVCINbXv2lAUoMBC4LtDtfn2LgCKM9PGoC1JjqrgE%2FNxoFptE2zyEOeRsr8%2BiqSD6F1zszDQkeEDWExIAgcR2YhvOmzeEwxF5Qvo05AdR5mzyoiGkfKQw6OADhhaU6XwrQXEmIOa3KjUC8Y8VRexYSBVaW0ATq9t8BVozh0oO3oY8S7gN4DfTtVo74K3OZiFD%2B4RflEk9510eUIy49270s3u4PYGbqkfbNNKe0%2FkpJVA1d2AwhWMDYIiQzvbCxvPkCFZmR9tDDRJfeFvMlSuoCJKPHZP6fa%2BvKRejYHw1oPNE7YHKY25dhzlFMbc8J1prFc28m6NO%2BEUaBMb7rBWHSPmbg7KAeUCq3GoHQqVnzG%2BN2kA%2FEvAA4CF5LBKiI1X%2Bc0LrslBMV%2B46nGUTxQNA%2FuVboVY16apwGdUqbB0EwYdJdX%2BsFEUFQvtd9Miaq3IwaAn5PVqY3E9QaMu80492pCYSx4U704gg06nLqY3MoJdRjVO4dAYaq2I%2F%2BEn%2FAYOZ4tPGZLGLsFQWZ%2BQhKjwgXYti7wVM0oLbFD8UQ8%2BdjBAgsGe6RqIlX3mHtxnQYeNDWsJp0vPAdLrBgcKaDpsg%2BqqV8rCWWKqlC68SvTDoBMl8iTQCQFOdExsoaWE914pBVJb%2BDlrx2mnMBgM4jw97inMxm5%2Ba4BOiIaK6gkvzqpuKO2Go6u9bxU%2BuflGtxZZCUkJHcRhphEvtkMLNrKz1QAh3UG9PeVtM0Fn5FTUdHqtBgdjYOiA3EYT8jJEiDwBdG7GfKNj0%2BariOKuusHoLqWVMOgp%2FLBtDG%2BD99ZNaXeTpsWtlWjGLLNg0Era3Xiwm%2FwtJEFFePDMO0L6X7iX9Ex7HYAb9QDypkzb68gYe6AjbTXbCWQssASSXnaqPPHR5FqT9Wqw1OjGPiu%2BjxCZbfohe5Psw%2FCKuHacJjUA5GWA51B1gFqrXGMeXoA1pafLK8q8uOTLvaOST0JzZfSWhna6ghcnPACYPyHV6sy6R76RfDgbdE6GBfChq8bwyNzkOz3QGToJRk4lJ4%2BLLm9fXc%2BjIDQBdNZ7oM8QU9lMFN1Lf8u7hVxPH9tAUDmkV82147Dv5UbDqTVaZ0fG3KySkhWnE6WhOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
