Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet
Infection, Human Immunodeficiency Virus
About this trial
This is an interventional health services research trial for Infection, Human Immunodeficiency Virus
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Males and females, 18 to 50 years of age, inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, 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:
i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
- Exposure to any investigational drug or placebo within 12 weeks of study drug administration
- Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1
Part 1: Prototype 1
Part 1: Prototype 2
Part 1: Prototype 3
Part 1: Prototype 4
Part 1: Prototype 5
Part 2
Part 2: Prototype 1
Part 2: Prototype 2
Part 2: Prototype 3
Part 2: Prototype 4
BMS-663068 1 × 600 mg extended-release (ER) tablet formulation
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)
BMS-663068 1 × 600 mg ER tablet formulation
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)