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A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol

A Randomized, Single Blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared With BGF MDI HFA in Healthy Subjects

NCT04600505•AstraZeneca

View on ClinicalTrials.gov

Summary

The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A \[test\]), Propellant 2 (Treatment B \[test\]) and Hydrofluoroalkane (HFA) (Treatment C \[reference\]).

Detailed Description

The study will comprise: * Screening period: up to 28 days prior to first dosing; * Three treatment periods of maximum 3 days each: participants will be resident from the morning of the day before the first dosing with BGF MDI (Day -1) in Treatment Period 1, throughout all treatment and washout periods up to discharge on Day 2 of Treatment Period 3; * Follow-up: within 3 to 7 days after the last administration of BGF MDI. There will be a washout period of 3 to 7 days between each dose. Each participant will receive 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \[Treatment A\]; 1 dose Propellant 2 \[Treatment B\] and 1 dose HFA \[Treatment C\]), following an overnight fast of at least 8 hours. Each participant will be involved in the study for up to 53 days.

Eligibility

Age

18 - 60 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Provision of signed and dated, written informed consent prior to any study specific procedures.
•Non-smoking male participants with suitable veins for cannulation or repeated venipuncture.
•Participants must agree to follow the reproductive restrictions.
•Have a body mass index between 18 and 30 kg/m\^2 and weigh at least 50 kg and no more than 100 kg.
•Participants must have a forced expiratory volume in one second ≥ 80% of the predicted value regarding age, height, and ethnicity at the screening visit.

Exclusion Criteria

•History or current evidence of a clinically significant (CS) disease or disorder (including but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary).
•History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
•Any CS illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
•Narrow angle glaucoma not adequately treated. All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non-selective β-blockers.
•Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the principal investigator (PI), is CS.
•Any cancer except squamous cell and basal cell carcinomas of the skin are allowed in the study.
•Any CS abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and/or admission to the Clinical Unit:
•1. Systolic blood pressure (BP) \< 90 mmHg or \> 140 mmHg.
•2. Diastolic BP \< 50 mmHg or \> 90 mmHg.
•3. Heart rate \< 45 or \> 85 bpm.
+25 more criteria

Locations (1)

Research Site

Glendale, California, United States

Key Dates

Start Date

October 19, 2020

Primary Completion Date

May 17, 2021

Completion Date

May 17, 2021

Last Updated

January 23, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Treatment A

DRUG

Treatment B

DRUG

Treatment C

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A