Healthy Participants
Conditions
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.
Interventions
DRUGBMS-986278
Oral administration 30 mg
DRUGRifampin
Oral administration 600 mg
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
Exclusion criteria
* 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 or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator * 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 Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) for Rifampin | Day 8 |
| Time of maximum observed plasma concentration (Tmax) for Rifampin | Day 8 |
| Incidence of non-serious adverse events (AE) | Up to 24 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin | Day 8-9 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin | Day 8-9 |
| 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 |
Countries
United States
Outcome results
None listed