Infection, Human Immunodeficiency Virus
Conditions
Brief summary
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
Detailed description
Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed
Interventions
DRUGBMS-955176
BMS-955176
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
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (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) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
| Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
| Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations | Up to Period 4/Day 4 (discharge) |
| Terminal plasma half-life (T-HALF) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
| Apparent total body clearance (CLT/F) of BMS-955176 | Days 1-4 of Periods 1, 2, 3 and 4 |
Countries
United Kingdom
Outcome results
None listed