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

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT02063360
Collaborator
GlaxoSmithKline (Industry)
42
Enrollment
3
Arms
3.3
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BMS-663068
  • Drug: Darunavir (DRV)
  • Drug: Ritonavir (RTV)
  • Drug: Etravirine (ETR)
 Phase 1

Detailed Description

Brief title: drug-drug interaction (DDI)

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

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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 Start Date :
Feb 1, 2014
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 13, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: BMS-663068
BMS-663068

Drug: Darunavir (DRV)
Darunavir (DRV)
Other Names:
  • Prezista

    • Drug: Ritonavir (RTV)
    Ritonavir (RTV)
    Other Names:
  • Norvir

    		•
    Experimental: 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

    Drug: BMS-663068
    BMS-663068

    Drug: Etravirine (ETR)
    Etravirine (ETR)
    Other Names:
  • Intelence

    		•
    Experimental: 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

    Drug: BMS-663068
    BMS-663068

    Drug: Darunavir (DRV)
    Darunavir (DRV)
    Other Names:
  • Prezista

    • Drug: Ritonavir (RTV)
    Ritonavir (RTV)
    Other Names:
  • Norvir

    • Drug: Etravirine (ETR)
    Etravirine (ETR)
    Other Names:
  • Intelence

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of BMS-626529 [20 timepoints up to day 26]

    2. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529 [20 timepoints up to day 26]

    Secondary Outcome Measures

    1. Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR [Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)]

    2. Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR [Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)]

    3. Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR [Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)]

    4. Cmax for DRV, RTV, and ETR [24 timepoints up to 26 day]

    5. AUC(TAU) for DRV, RTV, and ETR [24 timepoints up to 26 day]

    6. 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 [Up to day 27]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ViiV Healthcare
    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, ViiV Healthcare

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ViiV Healthcare
    ClinicalTrials.gov Identifier:
    NCT02063360
    Other Study ID Numbers:
    • 206281
    • AI438-020
    First Posted:
    Feb 14, 2014
    Last Update Posted:
    Aug 8, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Ritonavir
    Darunavir
    Fostemsavir
    Etravirine

    Study Results

    No Results Posted as of Aug 8, 2017