Study identifier:D6401C00003
ClinicalTrials.gov identifier:NCT03843060
EudraCT identifier:N/A
CTIS identifier:N/A
A phase 1 single center open-label, non-randomized, fixed sequence study in healthy volunteers to assess the pharmacokinetics (PK) of AZD9977 when administered alone and with itraconazole
Heart Failure with Preserved Ejection Fraction (HFpEF)
Phase 1
Yes
AZD9977, Itraconazole
All
14
Interventional
18 Years - 55 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2021 by AstraZeneca
AstraZeneca
-
This is an open-label, non-randomized, fixed sequence study conducted at a single study center with primary aim to assess the pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole.
This is an open-label, non-randomized, fixed sequence study conducted at a single study center with primary aim to assess the pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole. Two types of treatments (treatment period 1 and treatment period 2) will be administered in a fixed order separated by a washout period of 3 days or more. Treatment period 1 will be single dose of AZD9977 (Dose 1) administration, in the fed state, on Day 1 followed by at least 3 days washout period. For treatment period 2, Itraconazole will be administered daily (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) will be administered as a single dose on Day 7. Dose of itraconazole has to be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977.
Location
Location
Baltimore, MD, United States, 21225
Arms | Assigned Interventions |
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Experimental: Single AZD9977 During this treatment period, healthy participants will be administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. | Drug: AZD9977 Participants will receive single AZD9977 (Dose 1) capsule orally once daily in fed state, on Day 1 followed by at least 3 days washout period. Other Name: NA |
Experimental: Itraconazole + AZD9977 During this treatment period, healthy participants will be administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus will be administrated with AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole will be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. | Drug: Itraconazole Participants will receive Itraconazole daily (Dose 2) capsule orally once daily from Day 4 to Day 8 plus will be administered AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole has to be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. Other Name: Sporanox |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Participants who met all the inclusion and none of the exclusion criteria were enrolled at Parexel Early Phase Clinical Unit Baltimore |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment. |
Description | |
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Overall Study | All participants were administered AZD9977 orally, alone and in combination with multiple doses of itraconazole |
Overall Study | |
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STARTED | 14 |
COMPLETED | 14 |
NOT COMPLETED | 0 |
Description | |
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Overall Study | All participants were administered AZD9977 orally, alone and in combination with multiple doses of itraconazole |
Overall Study | |
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Number of Participants
[units: Participants] |
14 |
Age Continuous [units: years] Mean ± Standard Deviation |
43.4 ± 8.05 |
Sex: Female, Male [units: ] |
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Female | 1 |
Male | 13 |
Race (NIH/OMB) [units: ] |
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American Indian or Alaska Native | 0 |
Asian | 0 |
Native Hawaiian or Other Pacific Islander | 0 |
Black or African American | 13 |
White | 0 |
More than one race | 0 |
Unknown or Not Reported | 1 |
Measure Type | Primary |
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Measure Name | Area under plasma concentration-time curve from time zero to infinity (AUC) |
Measure Description | To assess pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Area under plasma concentration-time curve from time zero to infinity (AUC) [units: h*nmol/L] Geometric Mean (Geometric Coefficient of Variation) |
9341 (36.52%) | 28960 (17.63%) |
Groups [1] | All groups |
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Other [5] | 310.07 |
90% Confidence Interval | ( 273.75 to 351.20 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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No text entered. | |
[5] | Other relevant estimation information: |
No text entered. |
Measure Type | Primary |
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Measure Name | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) [units: h*nmol/L] Geometric Mean (Geometric Coefficient of Variation) |
9135 (37.12%) | 28750 (17.73%) |
Groups [1] | All groups |
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Other [5] | 314.76 |
90% Confidence Interval | ( 277.91 to 356.49 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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No text entered. | |
[5] | Other relevant estimation information: |
No text entered. |
Measure Type | Primary |
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Measure Name | Maximum observed plasma concentration (Cmax) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Maximum observed plasma concentration (Cmax) [units: nmol/L] Geometric Mean (Geometric Coefficient of Variation) |
2244 (30.76%) | 4992 (15.86%) |
Groups [1] | All groups |
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Other [5] | 222.44 |
90% Confidence Interval | ( 191.72 to 258.09 ) |
[1] | Additional details about the analysis, such as null hypothesis and power calculation: |
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No text entered. | |
[5] | Other relevant estimation information: |
No text entered. |
Measure Type | Secondary |
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Measure Name | Time to reach Maximum Observed Plasma Concentration (tmax) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Time to reach Maximum Observed Plasma Concentration (tmax) [units: hour] Median (Full Range) |
2.00 (1.00 to 3.00) | 2.26 (1.00 to 4.00) |
Measure Type | Secondary |
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Measure Name | Terminal elimination rate constant (λz) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Terminal elimination rate constant (λz) [units: 1/hour] Mean (Standard Deviation) |
0.13403 (0.097076) | 0.087065 (0.027397) |
Measure Type | Secondary |
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Measure Name | Terminal half life (t½λz) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Terminal half life (t½λz) [units: hour] Mean (Standard Deviation) |
7.695 (5.127) | 8.616 (2.380) |
Measure Type | Secondary |
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Measure Name | Mean residence time (MRT) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Mean residence time (MRT) [units: hour] Mean (Standard Deviation) |
6.059 (2.165) | 7.269 (0.8643) |
Measure Type | Secondary |
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Measure Name | Apparent plasma clearance (CL/F) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Apparent plasma clearance (CL/F) [units: L/h] Mean (Standard Deviation) |
28.55 (11.70) | 8.772 (1.596) |
Measure Type | Secondary |
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Measure Name | Apparent volume of distribution at terminal phase (Vz/F) |
Measure Description | To assess PK of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole |
Time Frame | Day 1 to 3: Pre-dose on Day 1, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose. Day 4 to 9: pre-dose on Day 7 and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hours post-dose |
Safety Issue? | No |
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. |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
Itraconazole + AZD9977 | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | Itraconazole + AZD9977 | |
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Number of
Participants Analyzed [units:participants] |
14 | 14 |
Apparent volume of distribution at terminal phase (Vz/F) [units: L] Mean (Standard Deviation) |
308.9 (248.6) | 110.3 (40.24) |
Time Frame | From screening (Day -28) till follow-up visit (5 to 7 days after discharge) |
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Additional Description | No text entered. |
Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
AZD9977+Itraconazole | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | AZD9977+Itraconazole | |
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Total, serious adverse events | ||
# participants affected / at risk | 0/14 (0.00%) | 0/14 (0.00%) |
Time Frame | From screening (Day -28) till follow-up visit (5 to 7 days after discharge) |
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Additional Description | No text entered. |
Threshold above which other adverse events are reported | 0% |
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Description | |
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AZD9977 | Healthy participants were administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
AZD9977+Itraconazole | Healthy participants were administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole was taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
AZD9977 | AZD9977+Itraconazole | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 1/14 (7.14%) | 1/14 (7.14%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gastrointestinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Constipation1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 1/14 (7.14%) | 0/14 (0.00%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# events | 1 | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
General disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Influenza like illness1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 0/14 (0.00%) | 1/14 (7.14%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# events | 0 | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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:
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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 |
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No text entered. |
Name/Title: | AstraZeneca Clinical Study Information Center |
Organization: | AstraZeneca AB |
Phone | 1-877-240-9479 |
E-mail: | [email protected] |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.