Food Effect Study With BMS-955176

ViiV Healthcare

Status and phase

Completed

Phase 1

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: BMS-955176

Study type

Interventional

Funder types

Industry

Identifiers

NCT02273947

206221

Details and patient eligibility

About

The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

Full description

Primary Purpose

Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg)/[Height (m)]2
Men and women, ages 18 to 50 years, inclusive
Women must not be of childbearing potential, must not be breastfeeding

Exclusion criteria

Any significant acute or chronic medical illness
History of cardiac disease or clinically significant cardiac arrhythmias
Current or recent (within 3 months of study drug administration) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 21 patient groups

Arm 1 (ABDC): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 2 (BCAD): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 3 (CDBA): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 4 (DACB): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 5 (EFHG): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 6 (FGEH): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 7 (GHFE): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 8 (HEGF): BMS-955176

Experimental group

Description:

BMS-955176 single dose by mouth for each treatment as specified

Treatment:

Drug: BMS-955176

Arm 9 (IJK): BMS-955176

Experimental group

Description: