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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Treatment B: BGF MDI HFA; Drug: Treatment A: BGF MDI HFO

Study type: Interventional

Funder types: Industry

Identifiers

NCT06723756

D598AC00001

Details and patient eligibility

About

This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.

Full description

This is a Phase I, randomized, double-blind, single-dose, single-site, three way cross-over study to assess the pharmacokinetic (PK) and safety of BGF MDI with HFO propellant compared with BGF MDI with HFA propellant in healthy participants (male or female).

The study will comprise of:

• A Screening period of up to 27 days;
• Three Treatment periods: Participants will receive a single dose of the study intervention on three separate occasions (Period 1, Period 2 and Period 3), with the final dose on Day 2 of Treatment Period 3, and a washout period of 5 to 7 days between administration of each dose;
• A final Safety Follow-up within 5 to 7 days after the last administration of the study intervention in Treatment Period 3.

Participants will receive all the treatments as a single dose (2 inhalations) (Treatment A [BGF MDI HFO - test formulation], and Treatment B [BGF MDI HFA - reference formulation]) in one of the 3 possible treatment sequences: ABB, BAB, or BBA. Each participant will be involved in the study for up to 52 days.

Enrollment: 105 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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105 participants in 2 patient groups

BGF MDI HFO

Experimental group

Description:

Participants will receive single doses (2 inhalations as a single dose) of test formulation BGF MDI HFO

Treatment:

Drug: Treatment A: BGF MDI HFO

BGF MDI HFA

Active Comparator group

Description:

Participants will receive single doses (2 inhalations as a single dose) of reference formulation BGF MDI HFA

Treatment:

Drug: Treatment B: BGF MDI HFA