Food Effect Study With BMS-955176

• Status: Completed
• Trial end date: 2016-08-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: BMS-955176

Criteria

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