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A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277600
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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Brief Summary:
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Drug: Darunavir Drug: Cobicistat Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects
Actual Study Start Date : November 5, 2014
Actual Primary Completion Date : January 12, 2015
Actual Study Completion Date : January 12, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1, Treatment A, B

Treatment A:

BMS-663068 orally twice daily (BID) on Days 1 through 4

Treatment B:

BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14

 Drug: BMS-663068
BMS-663068

Drug: Darunavir
Darunavir

Drug: Cobicistat
Cobicistat
Experimental: Cohort 2, Treatment C, D

Treatment C:

BMS-663068 orally BID on Days 1 through 4

Treatment D:

BMS-663068 orally BID plus COBI QD on Days 5 through 14

 Drug: BMS-663068
BMS-663068

Drug: Cobicistat
Cobicistat


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529 [ Time Frame: predose and up to 12 hours post dose on Days 4 and 14 ]
    In the presence or absence of multiple doses of DRV/COBI or COBI


Other Outcome Measures:
  1. Safety as assessed by adverse events and other physical parameters [ Time Frame: From dosing (Day 1) to Day 14 ]
    Collection of adverse events and other physical parameters to assess safety and tolerability


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 the duration of the study plus 34 days post-treatment completion

Exclusion Criteria:

  • Any history of acute or chronic medical and surgical illness.
  • Personal of family history of hemophilia A or B
  • Other protocol defined exclusion criteria could apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277600


Locations
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United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
More Information
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02277600    
Other Study ID Numbers: 206285
AI438-044 ( Other Identifier: Bristol-Myers Squibb )
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Darunavir
 Cobicistat
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors