Infection, Human Immunodeficiency Virus
Conditions
Brief summary
The current food effect study is being performed to support a Phase 3 study with BMS 663068. Results from this study will inform whether patients in the upcoming Phase 3 study can be given the flexibility to dose BMS-663068 in the fasted state, if so desired.
Detailed description
Primary Purpose: Other: To assess the effect of food on the steady-state exposure of BMS-626529 when administered as BMS 663068 600 mg twice daily (BID) to healthy subjects Acquired Immune Deficiency Syndrome (AIDS)
Interventions
DRUGBMS-663068
BMS-663068
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 and surgical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results * Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive * Males and Females, ages 18 to 50 years, inclusive * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to the start of study drug
Exclusion criteria
* Any significant acute or chronic medical illness as determined by the investigator * Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug * Any major surgery within 4 weeks of study drug administration * Any gastrointestinal surgery that could impact upon the absorption of study drug * Inability to tolerate oral medication * Recent (within 6 months of study drug administration) history of smoking or current smokers * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations beyond what is consistent with the target population * Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat: * PR ≥ 210 msec * QRS ≥ 120 msec * QT ≥ 500 msec * QTcF ≥ 450 msec * Positive urine screen for drugs of abuse * Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1 (HIV-1), -2 antibodies, and HIV-1 RNA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food | Days 1-4 of Periods 1 and 2 |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food | Days 1-4 of Periods 1 and 2 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints including incidence of Adverse events (AEs), serious AEs, AEs leading to discontinuations, deaths, and the results of vital signs, ECGs, physical examinations, and clinical laboratory tests | Approximately up to 41 days |
| Time of maximum observed plasma concentration (Tmax) of BMS-626529 | Day 4 of each period |
| Plasma concentration observed at 12 hours postdose (C12) of BMS-626529 | Day 4 of each period |
| Trough observed plasma concentration (Ctrough) of BMS-626529 | Days 1-4 of each period |
Countries
United States
Outcome results
None listed