A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)
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
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2020
CompletedStudy Start
First participant enrolled
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2020
CompletedMay 10, 2022
May 1, 2022
3 months
July 9, 2020
May 5, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum plasma concentration (Cmax) of BMS-986278
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
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
Up to 5 days
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (4)
Treatment A: BMS-986278 suspension, fasted
EXPERIMENTALTreatment B: BMS-986278 tablet, fasted
EXPERIMENTALTreatment C: BMS-986278 tablet, fed
EXPERIMENTALTreatment D: BMS-986278 tablet + esomeprazole capsule, fasted
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON (LPRA) - Salt Lake
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 13, 2020
Study Start
July 10, 2020
Primary Completion
October 7, 2020
Study Completion
October 7, 2020
Last Updated
May 10, 2022
Record last verified: 2022-05