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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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

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

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Brooklyn, Maryland, United States