Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

ViiV Healthcare

Status and phase

Completed

Phase 1

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: BMS-663068

Study type

Interventional

Funder types

Industry

Identifiers

NCT02164045

206283

AI438-042 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment

38 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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