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Completed

NCT Number: NCT02480894

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

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.

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-663068

Drug

BMS-663068

Maraviroc

Drug

Maraviroc

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2015
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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