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Food Effect Study With BMS-95...

Food Effect Study With BMS-955176

NCT ID: NCT02273947

Last Updated: 2017-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-23

Study Completion Date

2016-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm 1 (ABDC): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 2 (BCAD): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 3 (CDBA): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 4 (DACB): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 5 (EFHG): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 6 (FGEH): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 7 (GHFE): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 8 (HEGF): BMS-955176

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 9 (IJK): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 10 (JKI): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 11 (KIJ): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 12 (IKJ): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 13 (JIK): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 14 (KJI): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 15 (LMN): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 16 (OPQ): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 17 (PQO): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 18 (QOP): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 19 (OQP): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 20 (POQ): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Arm 21 (QPO): BMS-955176

BMS-955176 single dose by mouth for each treatment specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose by mouth for each treatment specified

Interventions

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BMS-955176

Single dose by mouth for each treatment specified

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Ruddington Fields, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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206221

Identifier Type: -

Identifier Source: org_study_id

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