An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
- Registration Number
- NCT03563950
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening
Exclusion Criteria
- Women of childbearing potential
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy
Other protocol defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rifampin + BMS-986224 Rifampin Oral administration Rifampin + BMS-986224 BMS-986224 Oral administration
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 5 days Maximum observed plasma concentration (Cmax) of BMS-986224 5 days Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 5 days
- Secondary Outcome Measures
Name Time Method Incidence of AEs leading to discontinuation 17 days Biomarker plasma concentrations of BMS-986224 5 days Time of maximum observed plasma concentration (Tmax) of BMS-986224 5 days Terminal elimination half-life (T-HALF) of BMS-986224 5 days Metabolite of BMS-986224 Cmax 5 days Metabolite of BMS-986224 AUC(0-T) 5 days Metabolite of BMS-986224 AUC(INF) 5 days Incidence of nonserious adverse events (AE) 17 days Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests 18 days Incidence of serious adverse events (SAE) 30 days
Trial Locations
- Locations (1)
PRA Health Sciences
🇺🇸Salt Lake City, Utah, United States