Food Effect Study With BMS-955176
- Registration Number
- NCT02273947
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
- Detailed Description
Primary Purpose
Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg)/[Height (m)]2
- Men and women, ages 18 to 50 years, inclusive
- Women must not be of childbearing potential, must not be breastfeeding
Exclusion Criteria
- Any significant acute or chronic medical illness
- History of cardiac disease or clinically significant cardiac arrhythmias
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 18 (QOP): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 1 (ABDC): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 2 (BCAD): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 3 (CDBA): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 19 (OQP): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 5 (EFHG): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 8 (HEGF): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 16 (OPQ): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 11 (KIJ): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 14 (KJI): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 13 (JIK): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 15 (LMN): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 17 (PQO): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 20 (POQ): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 7 (GHFE): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 9 (IJK): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 12 (IKJ): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 4 (DACB): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 6 (FGEH): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment as specified Arm 10 (JKI): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified Arm 21 (QPO): BMS-955176 BMS-955176 BMS-955176 single dose by mouth for each treatment specified
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176 Up to Day 4 of Period 4 Plasma concentration at 24 hours post-dose (C24) for BMS-955176 Up to Day 4 of Period 4 Maximum observed plasma concentration (Cmax) for BMS-955176 Up to Day 4 of Period 4 Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176 Up to Day 4 of Period 4
- Secondary Outcome Measures
Name Time Method Safety and tolerability Up to 30 days post discontinuation of dosing Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Ruddington Fields, Nottinghamshire, United Kingdom