An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants
1 other identifier
interventional
39
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2018
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
Study Start
First participant enrolled
September 6, 2018
CompletedFirst Submitted
Initial submission to the registry
October 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2018
CompletedJune 12, 2019
June 1, 2019
2 months
October 17, 2018
June 10, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Maximum observed plasma concentration (Cmax) for BMS-986278
Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278
Up to 24 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278
Day 1 and 8
Terminal phase half-life (T-HALF) for BMS-986278
Day 1 and 8
Secondary Outcomes (8)
Incidence of non-serious adverse events (AE)
Up to 24 days
Incidence of serious adverse events (SAE)
Up to 24 days
Incidence of AE leading to discontinuation
Up to 24 days
Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests
Up to 24 days
Maximum observed plasma concentration (Cmax) for Rifampin
Day 8
- +3 more secondary outcomes
Study Arms (1)
BMS-986278 + Rifampin
EXPERIMENTALTreatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
You may not qualify if:
- Women who are of childbearing potential 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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- History of significant cardiovascular disease
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Science KK
Lenexa, Kansas, 66219, 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2018
First Posted
October 19, 2018
Study Start
September 6, 2018
Primary Completion
November 8, 2018
Study Completion
November 8, 2018
Last Updated
June 12, 2019
Record last verified: 2019-06