A study to investigate the exposure of budesonide, glycopyrronium, and formoterol (BGF) delivered by hydrofluoroolefin (HFO) propellant metered dose inhaler (MDI) compared to a hydrofluoroalkane (HFA) propellant MDI in healthy adults

Study identifier:D598AC00001

ClinicalTrials.gov identifier:NCT06723756

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Phase I, randomized, double-blind, single-dose, partial replicate, 3-way cross-over study to assess the total systemic exposure bioequivalence of budesonide, glycopyrronium, and formoterol delivered by BGF MDI HFO compared with BGF MDI HFA in healthy adult participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A: BGF MDI HFO, Treatment B: BGF MDI HFA

Sex

All

Estimated Enrollment

105

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 23 Jan 2025

Estimated Primary Completion Date: 30 Jun 2025

Estimated Study Completion Date: 30 Jun 2025

Study design

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

Verification:

Verified 01 Dec 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
- Participants must have a forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value (based on age, height, ethnicity and gender at birth) and an FEV1/forced vital capacity (FEV1/FVC) > 70% at the Screening Visit. FEV1/FVC can be reported as ratio ie, 0.7 or a percentage ie, 70%.
- Participants must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.

Exclusion Criteria

- History of any clinically significant disease that put the participant at risk of participation.
- 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, history of narrow angle glaucoma not adequately treated, or bladder neck obstruction/urinary retention.
- Unresectable cancer that has not been in complete remission for at least 5 years.
- Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis results, 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, or human immunodeficiency virus (HIV) antibodies.
- History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
- Known or suspected history of alcohol or drug abuse as judged by the Investigator.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes).
- Excessive intake of caffeine-containing drinks or food.

No locations available

Arms	Assigned Interventions
Experimental: BGF MDI HFO Participants will receive single doses (2 inhalations as a single dose) of test formulation BGF MDI HFO	Drug: Treatment A: BGF MDI HFO Participants will receive 2 inhalations of BGF MDI HFO (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 1 Treatment period. Other Name: Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFO
Active Comparator: BGF MDI HFA Participants will receive single doses (2 inhalations as a single dose) of reference formulation BGF MDI HFA	Drug: Treatment B: BGF MDI HFA Participants will receive 2 inhalations of BGF MDI HFA (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 2 Treatment periods. Other Name: Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFA

Documents available

Thank You Card
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Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]