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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
38
BMS-663068
GSK Investigational Site
San Antonio, Texas, United States
Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food
Time frame: 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
Time frame: Days 1-4 of Periods 1 and 2
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
Time frame: Approximately up to 41 days
Time of maximum observed plasma concentration (Tmax) of BMS-626529
Time frame: Day 4 of each period
Plasma concentration observed at 12 hours postdose (C12) of BMS-626529
Time frame: Day 4 of each period
Trough observed plasma concentration (Ctrough) of BMS-626529
Time frame: Days 1-4 of each period
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