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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-24

Study Completion Date

2014-07-25

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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BMS-663068- Fasted

BMS-663068 tablet twice a day by mouth on specified days

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

BMS-663068- Fed

BMS-663068 tablet twice a day by mouth on specified days

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Interventions

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BMS-663068

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes