A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Study identifier:PT010011

ClinicalTrials.gov identifier:NCT03311373

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Regimen A, Regimen B, Regimen C, Regimen D

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 40 Years

Date

Study Start Date: 17 Oct 2017

Primary Completion Date: 15 Dec 2017

Study Completion Date: 15 Dec 2017

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2020 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
-Male and female subjects 18 to 40 years of age, inclusive
-Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
-Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
-Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period
-Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.
-Demonstrate correct MDI administration technique

Exclusion Criteria

-For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
-Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
-Subjects who have cancer that has not been in complete remission for at least 5 years
-Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
-Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
-History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening
-History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting
-A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period
-Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use
-Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period
-Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
-Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject’s unwillingness to comply with study-related procedures)

Location

Pearl Investigative Site

Baltimore, MD, United States, 21201

Arms	Assigned Interventions
Experimental: Treatment Period 1 Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)	Drug: Regimen A 2 inhalations BGF MDI; no spacer device; no oral charcoal – reference formulation/total systemic exposure Drug: Regimen B 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal – test formulation/total systemic exposure Drug: Regimen C 2 inhalations BGF MDI; no spacer device; with oral charcoal – reference formulation/lung exposure Drug: Regimen D 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal – test formulation/lung exposure
Experimental: Treatment Period 2 Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)	Drug: Regimen A 2 inhalations BGF MDI; no spacer device; no oral charcoal – reference formulation/total systemic exposure Drug: Regimen B 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal – test formulation/total systemic exposure Drug: Regimen C 2 inhalations BGF MDI; no spacer device; with oral charcoal – reference formulation/lung exposure Drug: Regimen D 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal – test formulation/lung exposure
Experimental: Treatment Period 3 Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)	Drug: Regimen A 2 inhalations BGF MDI; no spacer device; no oral charcoal – reference formulation/total systemic exposure Drug: Regimen B 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal – test formulation/total systemic exposure Drug: Regimen C 2 inhalations BGF MDI; no spacer device; with oral charcoal – reference formulation/lung exposure Drug: Regimen D 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal – test formulation/lung exposure
Experimental: Treatment Period 4 Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)	Drug: Regimen A 2 inhalations BGF MDI; no spacer device; no oral charcoal – reference formulation/total systemic exposure Drug: Regimen B 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal – test formulation/total systemic exposure Drug: Regimen C 2 inhalations BGF MDI; no spacer device; with oral charcoal – reference formulation/lung exposure Drug: Regimen D 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal – test formulation/lung exposure

Documents available

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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Paul M. Dorinsky

Pearl Therapeutics, Inc.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Pearl Investigative Site

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Trial Results Summaries

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=PT010011&attachmentIdentifier=101b3e8b-ad61-40b9-a1b0-4edfb4c6fb48&fileName=PT010011_SAP__v1.0_16J_Jan_2018_Redacted_Final_PDF-A.pdf&versionIdentifier=

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