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

NCT ID: NCT02480894

Last Updated: 2017-09-25

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-07

Study Completion Date

2015-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Maraviroc

Intervention Type DRUG

Maraviroc

Interventions

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BMS-663068

BMS-663068

Intervention Type DRUG

Maraviroc

Maraviroc

Intervention Type DRUG

Eligibility Criteria

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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
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

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Wire MB, Magee M, Ackerman P, Llamoso C, Moore K. Evaluation of the pharmacokinetic drug-drug interaction between the antiretroviral agents fostemsavir and maraviroc: a single-sequence crossover study in healthy participants. HIV Res Clin Pract. 2021 Dec 9;23(1):1-8. Epub 2022 Mar 14.

Reference Type DERIVED
PMID: 35285786 (View on PubMed)

Other Identifiers

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AI438-052

Identifier Type: OTHER

Identifier Source: secondary_id

206278

Identifier Type: -

Identifier Source: org_study_id