A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

September 20, 2017 updated by: ViiV Healthcare

A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects

This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.

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.

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.
112

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 States
    • Texas
      • San Antonio, Texas, United States, 78209
        • 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 male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
  • Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • Pre-existing liver dysfunction
  • Any significant acute or chronic medical illness
  • Orthostatic intolerance
  • Other protocol specified exclusion criteria could apply

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group 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: Sequential Dosing
Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18
Drug: BMS-663068
BMS-663068
Drug: Maraviroc
Maraviroc

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
Measure Description
Time Frame
BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)
Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:

- Cmax
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)
Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:

- AUC(TAU)
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Maraviroc Pharmacokinetics: Cmax
Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

PK parameters for maraviroc in the absence or presence of BMS-663068 include:

- Cmax
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Maraviroc Pharmacokinetics: AUC(TAU)
Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

PK parameters for maraviroc in the absence or presence of BMS-663068 include:

- AUC(TAU)
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

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
Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)
Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

PK parameters for BMS-626529 include:

- Tmax
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)
Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

PK parameters for BMS-626529 include:

- C12
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)
Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

PK parameters for BMS-626529 include:

- Ctrough (predose)
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for maraviroc: Tmax
Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

PK Parameters for maraviroc include:

-Tmax
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Other PK Parameters for maraviroc: C12
Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

PK Parameters for maraviroc include:

  • C12
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Other PK Parameters for maraviroc: Ctrough
Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

PK Parameters for maraviroc include:

- Ctrough
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Clinical Safety as Measured by Adverse Events
Time Frame: Day 1 to Day 26
Adverse event monitoring
Day 1 to Day 26
Clinical Safety as Measured by Vital Signs
Time Frame: Day 1 to Day 26
Vital sign measurement
Day 1 to Day 26
Clinical Safety as Measured by Electrocardiograms (ECGs)
Time Frame: Day 1 to Day 26
12-lead ECGs
Day 1 to Day 26
Clinical Safety as Measured by Physical Examination
Time Frame: Day 1 to Day 26
Physical examinations
Day 1 to Day 26
Clinical Safety as Measured by Clinical Laboratory Evaluations
Time Frame: Day 1 to Day 26
Clinical chemistry, hematology, urinalysis
Day 1 to Day 26

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

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.

General Publications

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.
July 7, 2015

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.
September 21, 2015

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.
September 21, 2015

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).
June 16, 2015

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.
June 22, 2015

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.
June 25, 2015

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.
September 25, 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.
September 20, 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.
September 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.
  • 206278
  • AI438-052 (Other Identifier: Bristol-Myers Squibb)

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.

Clinical Trials on Infection, Human Immunodeficiency Virus

Clinical Trials on BMS-663068

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings