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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-663068

Study type: Interventional

Funder types: Industry

Identifiers

NCT02666053

206295

AI438-071 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

72 participants in 3 patient groups

Treatment A

Experimental group

Description:

Single BMS-663068 tablet under fasted conditions

Treatment:

Drug: BMS-663068

Treatment B

Experimental group

Description:

Single BMS-663068 tablet with a high fat meal

Treatment:

Drug: BMS-663068

Treatment C

Experimental group

Description:

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

Treatment:

Drug: BMS-663068