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

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ClinicalTrials.gov Identifier: NCT02480894
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects
Actual Study Start Date : July 7, 2015
Actual Primary Completion Date : September 21, 2015
Actual Study Completion Date : September 21, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc

Arm Intervention/treatment
Experimental: 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
Drug: BMS-663068
BMS-663068

Drug: Maraviroc
Maraviroc




Primary Outcome Measures :
  1. BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax) [ Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18 ]

    PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:

    - Cmax


  2. BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU) [ Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18 ]

    PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:

    - AUC(TAU)


  3. Maraviroc Pharmacokinetics: Cmax [ Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 ]

    PK parameters for maraviroc in the absence or presence of BMS-663068 include:

    - Cmax


  4. Maraviroc Pharmacokinetics: AUC(TAU) [ Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 ]

    PK parameters for maraviroc in the absence or presence of BMS-663068 include:

    - AUC(TAU)



Secondary Outcome Measures :
  1. Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax) [ Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18 ]

    PK parameters for BMS-626529 include:

    - Tmax


  2. Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12) [ Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18 ]

    PK parameters for BMS-626529 include:

    - C12


  3. Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose) [ Time Frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18 ]

    PK parameters for BMS-626529 include:

    - Ctrough (predose)


  4. Other PK Parameters for maraviroc: Tmax [ Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 ]

    PK Parameters for maraviroc include:

    -Tmax


  5. Other PK Parameters for maraviroc: C12 [ Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 ]

    PK Parameters for maraviroc include:

    • C12

  6. Other PK Parameters for maraviroc: Ctrough [ Time Frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 ]

    PK Parameters for maraviroc include:

    - Ctrough


  7. Clinical Safety as Measured by Adverse Events [ Time Frame: Day 1 to Day 26 ]
    Adverse event monitoring

  8. Clinical Safety as Measured by Vital Signs [ Time Frame: Day 1 to Day 26 ]
    Vital sign measurement

  9. Clinical Safety as Measured by Electrocardiograms (ECGs) [ Time Frame: Day 1 to Day 26 ]
    12-lead ECGs

  10. Clinical Safety as Measured by Physical Examination [ Time Frame: Day 1 to Day 26 ]
    Physical examinations

  11. Clinical Safety as Measured by Clinical Laboratory Evaluations [ Time Frame: Day 1 to Day 26 ]
    Clinical chemistry, hematology, urinalysis



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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 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
  • Other protocol specified exclusion criteria could apply

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): NCT02480894


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

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02480894     History of Changes
Other Study ID Numbers: 206278
AI438-052 ( Other Identifier: Bristol-Myers Squibb )
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
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
Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists