Food Effect Study With BMS-955176

ViiV Healthcare12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Infection, Human Immunodeficiency Virus

Interventions

BMS-955176DRUG

Single dose by mouth for each treatment specified

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Ruddington Fields, Nottinghamshire, United Kingdom

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax) for BMS-955176

Time frame: Up to Day 4 of Period 4

Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176

Time frame: Up to Day 4 of Period 4

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176

Time frame: Up to Day 4 of Period 4

Plasma concentration at 24 hours post-dose (C24) for BMS-955176

Time frame: Up to Day 4 of Period 4

Secondary Outcomes

Safety and tolerability

Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)

Time frame: Up to 30 days post discontinuation of dosing

Data from ClinicalTrials.gov

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