Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.

NCT06139991 | Completed Phase 1 FDA Drug

• 1 other identifier: D6933C00001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.

Conditions

Heathy Participants

Keywords

Albuterol; Budesonide; Combination product; Hydrofluoralkene propellant; Hydrofluoroolefin propellant

Outcome Measures

Primary Outcomes (2)

• Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

  The AUClast of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.

  Day 1, Day 2 (pre-dose and post-dose)

• Maximum plasma drug concentration (Cmax)

  The Cmax of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.

  Day 1, Day 2 (pre-dose and post-dose)

Secondary Outcomes (10)

• Area under plasma concentration-time curve from time 0 to infinity (AUCinf)

  Day 1, Day 2 (pre-dose and post-dose)

• Time to reach maximum observed concentration (Tmax)

  Day 1, Day 2 (pre-dose and post-dose)

• Terminal elimination half-life (T1/2λz)

  Day 1, Day 2 (pre-dose and post-dose)

• Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)

  Day 1, Day 2 (pre-dose and post-dose)

• Apparent total body clearance (CL/F)

  Day 1, Day 2 (pre-dose and post-dose)

Study Arms (3)

Treatment sequence ABB

EXPERIMENTAL

Participants will receive Treatment A, followed by Treatment B, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration.

Drug: Treatment A (BDA MDI HFO); Drug: Treatment B (BDA MDI HFA)

Treatment sequence BBA

EXPERIMENTAL

Participants will receive Treatment B, followed by Treatment B, followed by Treatment A, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration.

Drug: Treatment A (BDA MDI HFO); Drug: Treatment B (BDA MDI HFA)

Treatment sequence BAB

EXPERIMENTAL

Participants will receive Treatment B, followed by Treatment A, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration.

Drug: Treatment A (BDA MDI HFO); Drug: Treatment B (BDA MDI HFA)

Interventions

Treatment A (BDA MDI HFO) DRUG

Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition.

Treatment sequence ABB; Treatment sequence BAB; Treatment sequence BBA

Treatment B (BDA MDI HFA) DRUG

Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.

Treatment sequence ABB; Treatment sequence BAB; Treatment sequence BBA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
• Female participants must have a negative pregnancy test at screening and on admission and must not be lactating.
• Participants with Body mass index between 18 and 30 kg/m\^2, inclusive, and weighing between 50 kg and no more than 120 kg inclusive.
• Participants must have a Forced expiratory volume (FEV)1 ≥ 80% of the predicted normal value and an FEV1/FVC\> 70% regarding age, height, and ethnicity at the screening visit.
• Participants must demonstrate proper inhalation technique and is able to use an MDI properly after training.

You may not qualify if:

• History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder.
• History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
• Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at the screening.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or Human immunodeficiency virus (HIV).
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
• Known or suspected history of alcohol or drug abuse.
• Positive screen for drugs of abuse, alcohol, or cotinine at screening.
• History or presence of severe allergy/hypersensitivity.
• Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug.
• Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of study drug.
• Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
• Excessive intake of caffeine-containing drinks or food.
• Vulnerable participants.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Since this is a double-blind study, so the investigator, all clinical staff involved in the clinical study, the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Partial-replicate, 3-period Cross-over study.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: November 16, 2023
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

US (1)