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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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