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Keep this study
Lead
ViiV Healthcare
With
GlaxoSmithKline
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)
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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
You may not be if
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
