NCT04600505

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Treatment A	Participants will receive 2 inhalations of BGF MDI with propellant 1.
DRUG	Treatment B	Participants will receive 2 inhalations of BGF MDI with propellant 2.
DRUG	Treatment C	Participants will receive 2 inhalations of BGF MDI with HFA propellant.

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2020-10-23
• Last updated: 2023-01-23
• Results posted: 2023-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study