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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BMS-663068
Darunavir (DRV)
Ritonavir (RTV)
Etravirine (ETR)
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1: BMS-663068+DRV/RTV

    Cohort 2: BMS-663068+ETR

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

    Arm Description

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    Maximum observed plasma concentration (Cmax) of BMS-626529
    Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529

    Secondary Outcome Measures

    Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR
    Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR
    Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR
    Cmax for DRV, RTV, and ETR
    AUC(TAU) for DRV, RTV, and ETR
    Safety and tolerability endpoints include incidence of adverse event (AEs), serious adverse event (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead ECGs

    Full Information

    First Posted
    February 13, 2014
    Last Updated
    August 7, 2017
    Sponsor
    ViiV Healthcare
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02063360
    Brief Title
    DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
    Official Title
    Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2014 (undefined)
    Primary Completion Date
    May 1, 2014 (Actual)
    Study Completion Date
    May 13, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ViiV Healthcare
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Brief title: drug-drug interaction (DDI) Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Human Immunodeficiency Virus

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1: BMS-663068+DRV/RTV
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Cohort 2: BMS-663068+ETR
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Cohort 3: BMS-663068+DRV/RTV+ETR
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    BMS-663068
    Intervention Description
    BMS-663068
    Intervention Type
    Drug
    Intervention Name(s)
    Darunavir (DRV)
    Other Intervention Name(s)
    Prezista
    Intervention Description
    Darunavir (DRV)
    Intervention Type
    Drug
    Intervention Name(s)
    Ritonavir (RTV)
    Other Intervention Name(s)
    Norvir
    Intervention Description
    Ritonavir (RTV)
    Intervention Type
    Drug
    Intervention Name(s)
    Etravirine (ETR)
    Other Intervention Name(s)
    Intelence
    Intervention Description
    Etravirine (ETR)
    Primary Outcome Measure Information:
    Title
    Maximum observed plasma concentration (Cmax) of BMS-626529
    Time Frame
    20 timepoints up to day 26
    Title
    Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529
    Time Frame
    20 timepoints up to day 26
    Secondary Outcome Measure Information:
    Title
    Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR
    Time Frame
    Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
    Title
    Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR
    Time Frame
    Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
    Title
    Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR
    Time Frame
    Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)
    Title
    Cmax for DRV, RTV, and ETR
    Time Frame
    24 timepoints up to 26 day
    Title
    AUC(TAU) for DRV, RTV, and ETR
    Time Frame
    24 timepoints up to 26 day
    Title
    Safety and tolerability endpoints include incidence of adverse event (AEs), serious adverse event (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead ECGs
    Time Frame
    Up to day 27

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    ViiV Healthcare
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35315687
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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