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

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068

• Registration Number: NCT02666053
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-25
• Study Start: 2016-01-27
• Study First Posted: 2016-01-28
• Primary Completion: 2016-02-22
• Study Completion: 2016-02-22
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	BMS-663068	Single BMS-663068 tablet under fasted conditions
Treatment B	BMS-663068	Single BMS-663068 tablet with a high fat meal
Treatment C	BMS-663068	Single BMS-663068 tablet after a single famotidine tablet under fasted conditions

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Days 1-12
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)	Days 1-12

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation	Days 1-12; for SAEs up to 30 days post discontinuation of dosing	Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States