Food Effect Study With BMS-955176

April 13, 2017 updated by: ViiV Healthcare

An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Ruddington Fields, Nottinghamshire, United Kingdom, NG11 6JS
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (ABDC): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 2 (BCAD): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 3 (CDBA): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 4 (DACB): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 5 (EFHG): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 6 (FGEH): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 7 (GHFE): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 8 (HEGF): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 9 (IJK): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 10 (JKI): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 11 (KIJ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 12 (IKJ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 13 (JIK): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 14 (KJI): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 15 (LMN): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 16 (OPQ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 17 (PQO): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 18 (QOP): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 19 (OQP): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 20 (POQ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified
Experimental: Arm 21 (QPO): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176
Single dose by mouth for each treatment specified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) for BMS-955176
Time Frame: Up to Day 4 of Period 4
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
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
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
Up to Day 4 of Period 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Up to 30 days post discontinuation of dosing
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)
Up to 30 days post discontinuation of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2014

Primary Completion (Actual)

August 15, 2016

Study Completion (Actual)

August 15, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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