NCT04468815CompletedPhase 1
An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants
Bristol-Myers Squibb1 site in 1 country24 target enrollmentStarted: July 10, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration (Cmax) of BMS-986278
Study Overview
Brief Summary
The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
- •Women and men must agree to follow specific methods of contraception
Exclusion Criteria
- •Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
- •Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
- •History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)
- •Other protocol-defined inclusion/exclusion criteria apply
Arms & Interventions
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
Experimental
Intervention: BMS-986278 Tablet (Drug)
Treatment A: BMS-986278 suspension, fasted
Experimental
Intervention: BMS-986278 suspension (Drug)
Treatment B: BMS-986278 tablet, fasted
Experimental
Intervention: BMS-986278 Tablet (Drug)
Treatment C: BMS-986278 tablet, fed
Experimental
Intervention: BMS-986278 Tablet (Drug)
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
Experimental
Intervention: Esomeprazole (Drug)
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax) of BMS-986278
Time Frame: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
Time Frame: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
Time Frame: Up to 5 days
Secondary Outcomes
- Incidence of Adverse Events (AEs)(Up to 29 days)
- Incidence of Serious Adverse (SAE's)(Up to 57 days)
- Incidence of AEs leading to discontinuation(Up to 29 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 48 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 48 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 48 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 48 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters(Up to 48 days)
- Incidence of clinically significant changes in physical examination findings(Up to 48 days)
- Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests(Up to 48 days)
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 48 days)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 48 days)
Investigators
Study Sites (1)
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