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DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

NCT ID: NCT02063360

Last Updated: 2017-08-08

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2014-05-13

Brief Summary

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The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.

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Detailed Description

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Brief title: drug-drug interaction (DDI)

Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1: BMS-663068+DRV/RTV

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Darunavir (DRV)

Intervention Type DRUG

Darunavir (DRV)

Ritonavir (RTV)

Intervention Type DRUG

Ritonavir (RTV)

Cohort 2: BMS-663068+ETR

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Etravirine (ETR)

Intervention Type DRUG

Etravirine (ETR)

Cohort 3: BMS-663068+DRV/RTV+ETR

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Darunavir (DRV)

Intervention Type DRUG

Darunavir (DRV)

Ritonavir (RTV)

Intervention Type DRUG

Ritonavir (RTV)

Etravirine (ETR)

Intervention Type DRUG

Etravirine (ETR)

Interventions

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BMS-663068

BMS-663068

Intervention Type DRUG

Darunavir (DRV)

Darunavir (DRV)

Intervention Type DRUG

Ritonavir (RTV)

Ritonavir (RTV)

Intervention Type DRUG

Etravirine (ETR)

Etravirine (ETR)

Intervention Type DRUG

Other Intervention Names

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Prezista Norvir Intelence

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests
* Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception

Exclusion Criteria

* Any significant acute or chronic medical condition
* Unable to tolerate oral medications
* Inability to be venipunctured and/or tolerate venous access
* Current or recent (within 3 months of dosing) gastrointestinal disease
* Abnormal liver function test
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

References

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Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.

Reference Type DERIVED
PMID: 35315687 (View on PubMed)

Other Identifiers

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AI438-020

Identifier Type: OTHER

Identifier Source: secondary_id

206281

Identifier Type: -

Identifier Source: org_study_id

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