A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

January 17, 2017 updated by: ViiV Healthcare

A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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 States
    • Texas
      • Austin, Texas, United States, 78744
        • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed Informed Consent
  2. Target population: Healthy males and females.
  3. Women of child bearing potential (WOCBP) with negative serum pregnancy test
  4. Women must not be breastfeeding
  5. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

  1. History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
  2. History of frequent headaches or acute diarrhoea.
  3. Any major surgery within 4 weeks of study drug administration
  4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
  5. History of allergy to HIV maturation and integrase inhibitors,or related compounds
  6. History of smoking

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
Single DTG tablet under fed conditions for a specified period
Drug: Dolutegravir
Dolutegravir
Experimental: Treatment B
Two BMS955176 tablets under fed conditions for a specified period
Drug: BMS955176
BMS955176
Experimental: Treatment C
Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period
Drug: Dolutegravir
Dolutegravir
Drug: BMS955176
BMS955176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) for DTG
Time Frame: Days 1 to 5 and days 15 to 21
Days 1 to 5 and days 15 to 21
Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG
Time Frame: Days 1 to 5 and days 15 to 21
Days 1 to 5 and days 15 to 21
Maximum observed plasma concentration (Cmax) for BMS-955176
Time Frame: Days 8-21
Days 8-21
Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176
Time Frame: Days 8-21
Days 8-21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: Days 1-21; for SAEs up to 30 days post discontinuation of dosing
The incidence of observed AEs will be tabulated and reviewed for potential significance and clinical importance.
Days 1-21; for SAEs 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206222
  • AI468-052 (Other Identifier: Bristol-Myers Squibb)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Subscribe