Infection, Human Immunodeficiency Virus
Conditions
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.
Interventions
DRUGBMS-955176
Single dose by mouth for each treatment specified
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 to 72 hours post-dose [AUC(0-72)] 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 |
| Plasma concentration at 24 hours post-dose (C24) for BMS-955176 | Up to Day 4 of Period 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United Kingdom
Outcome results
None listed