Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant

Completed · Phase 1

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The study will assess the Pharmacokinetic (PK) and safety of BGF MDI \[Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)\] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane (HFA) with oral activated charcoal in healthy subjects (male or female).

Key facts

Study ID: NCT05477108
Run by: AstraZeneca
People needed: 108
Starts: 2022-07-29
Expected to finish: 2023-04-11
Last updated by the study team: 2025-08-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy non-smoking male and/or female subjects aged 18 - 60 years with suitable veins for cannulation or repeated venipuncture.
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, confirmed at screening.
Have a Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
Subjects must have a Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/FVC (Forced vital capacity) > 70% regarding age, height, and ethnicity at the screening visit.
Subjects must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.
Provision of signed and dated, written informed consent prior to any study specific procedures.

You may not qualify if…

History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate.
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 clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
History of narrow angle glaucoma not adequately treated and/or change in vision that may be relevant.
History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention.
Unresectable cancer that has not been in complete remission for at least 5 years.
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Any clinically significant abnormal findings in physical examination, or vital signs at screening.
Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and HIV antibody.
Subject has a positive RT-PCR test for SARS-CoV-2 prior to randomization.
Subject has clinical signs and symptoms consistent with SARS-CoV-2 infection, eg, fever, dry cough, dyspnea, sore throat, fatigue, or laboratory confirmed acute infection with SARS-CoV-2.
Subject who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated, Intensive Care Unit stay).
Recent (within 14 days prior to admission to the Clinical Unit) exposure to someone who has COVID-19 symptoms or tested positive for SARS-CoV-2.
Has a current occupation that involves routine exposure to potential COVID-19 patients or sources of SARS-CoV-2 infection (eg, healthcare worker).
History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
Known or suspected history of drug abuse.
Receipt of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to BGF.
Current smokers or those who have smoked or used nicotine products (including e cigarettes) within 3 months prior to screening.
Positive screen for drugs of abuse or cotinine at screening or on admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit.
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP.
Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.

Where it is running

Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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