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

• Status: Completed
• Trial end date: 2016-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Fostemsavir

Criteria

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