Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529
- Registration Number
- NCT02164045
- Lead Sponsor
- ViiV Healthcare
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
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Any significant acute or chronic medical illness as determined by the investigator
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Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
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Any major surgery within 4 weeks of study drug administration
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Any gastrointestinal surgery that could impact upon the absorption of study drug
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Inability to tolerate oral medication
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Recent (within 6 months of study drug administration) history of smoking or current smokers
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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
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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
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Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1 (HIV-1), -2 antibodies, and HIV-1 RNA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BMS-663068- Fasted BMS-663068 BMS-663068 tablet twice a day by mouth on specified days BMS-663068- Fed BMS-663068 BMS-663068 tablet twice a day by mouth on specified days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Trough observed plasma concentration (Ctrough) of BMS-626529 Days 1-4 of each period 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 Plasma concentration observed at 12 hours postdose (C12) of BMS-626529 Day 4 of each period Time of maximum observed plasma concentration (Tmax) of BMS-626529 Day 4 of each period
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸San Antonio, Texas, United States