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

NCT03311373 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PT010011
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (6)

• Maximum Plasma Concentration (Cmax)-Budesonide

  Maximum plasma concentration (Cmax) per Regimen

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Maximum Plasma Concentration (Cmax)-Glycopyrronium

  Maximum plasma concentration (Cmax) per Regimen

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Maximum Plasma Concentration (Cmax)-Formoterol

  Maximum plasma concentration (Cmax) per Regimen

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide

  Each treatment period is equal to assigned regimen

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium

  Each treatment period is equal to assigned regimen

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol

  Each treatment period is equal to assigned regimen

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

Secondary Outcomes (6)

• Time to Maximum Plasma Concentration (Tmax)-Budesonide

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Time to Maximum Plasma Concentration (Tmax)-Formoterol

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

• Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium

  Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

Study Arms (4)

Treatment Period 1

EXPERIMENTAL

Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)

Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D

Treatment Period 2

EXPERIMENTAL

Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D

Treatment Period 3

EXPERIMENTAL

Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D

Treatment Period 4

EXPERIMENTAL

Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D

Interventions

Regimen A DRUG

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

Regimen B DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

Regimen C DRUG

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

Regimen D DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

Pearl Investigative Site

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Dorinsky P, DePetrillo P, DeAngelis K, Trivedi R, Darken P, Gillen M. Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults. Clin Ther. 2020 Apr;42(4):634-648. doi: 10.1016/j.clinthera.2020.02.012. Epub 2020 Apr 3.

  PMID: 32253054 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

OOS-A regimen; Regimen B

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pearl Therapeutics, Inc.
• Organization: Pearl Therapeutics, Inc.

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Paul M. Dorinsky, MD

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: October 17, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)