A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-27

Study Completion Date

2016-02-22

Brief Summary

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The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability

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Detailed Description

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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

Study Groups

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Treatment A

Single BMS-663068 tablet under fasted conditions

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Treatment B

Single BMS-663068 tablet with a high fat meal

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Treatment C

Single BMS-663068 tablet after a single famotidine tablet under fasted conditions

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

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Males and females
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
5. Women must not be breastfeeding
6. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria

1. History of any chronic or acute illness or gastrointestinal disease
2. Any major surgery within 4 weeks of study drug administration
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to HIV attachment inhibitors, famotidine or high fat meal
5. History of smoking

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes