Drug-Drug Interaction Study With Rifampin
- Registration Number
- NCT01002079
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive
Exclusion Criteria
- Women of childbearing potential
- Tuberculosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-708163 BMS-708163 - Rifampin Rifampin - Rifampin + BMS-708163 BMS-708163 - Rifampin + BMS-708163 Rifampin -
- Primary Outcome Measures
Name Time Method BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13) Within 30 days after dose
- Secondary Outcome Measures
Name Time Method BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs) Within 30 days after dose
Trial Locations
- Locations (1)
Local Institution
🇮🇳Bangalore, India