search
Back to results

Study on Pharmacokinetics

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rosuvastatin
BMS-663068
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections

Eligibility Criteria

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

Inclusion Criteria:

  1. Signed Informed Consent Form

    • Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.

  2. Target Population

    • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results.

  3. Age and Reproductive Status

    • Men and women of non-childbearing potential, ages 18 to 50 years, inclusive. Women must have documented proof that they are not of childbearing potential. Women must not be breastfeeding.
    • Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).

Exclusion Criteria:

  • Women who are of childbearing potential or breastfeeding
  • Any significant acute or chronic medical illness
  • History of rhabdomyolysis or biliary disorders, including Gilbert's disease or Dubin-Johnson disease
  • Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration)
  • Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1 week prior to the start of study drug administration and for the duration of the study
  • Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Rosuvastatin and BMS-663068

    Arm Description

    Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days

    Outcomes

    Primary Outcome Measures

    Maximum observed plasma concentration (Cmax) of rosuvastatin
    Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin

    Secondary Outcome Measures

    Trough blood samples of BMS-626529 concentration
    Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

    Full Information

    First Posted
    September 5, 2014
    Last Updated
    April 13, 2018
    Sponsor
    ViiV Healthcare
    Collaborators
    GlaxoSmithKline
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02234882
    Brief Title
    Study on Pharmacokinetics
    Official Title
    Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 5, 2014 (Actual)
    Primary Completion Date
    October 31, 2014 (Actual)
    Study Completion Date
    October 31, 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 assess the effect of the coadministration of multiple doses of BMS-663068 on the systemic exposure of rosuvastatin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rosuvastatin and BMS-663068
    Arm Type
    Experimental
    Arm Description
    Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    BMS-663068
    Primary Outcome Measure Information:
    Title
    Maximum observed plasma concentration (Cmax) of rosuvastatin
    Time Frame
    Days 1 through 13
    Title
    Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin
    Time Frame
    Days 1 through 13
    Secondary Outcome Measure Information:
    Title
    Trough blood samples of BMS-626529 concentration
    Time Frame
    Days 7 through 13
    Title
    Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
    Time Frame
    40 days

    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: Signed Informed Consent Form Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures. Target Population Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results. Age and Reproductive Status Men and women of non-childbearing potential, ages 18 to 50 years, inclusive. Women must have documented proof that they are not of childbearing potential. Women must not be breastfeeding. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s). Exclusion Criteria: Women who are of childbearing potential or breastfeeding Any significant acute or chronic medical illness History of rhabdomyolysis or biliary disorders, including Gilbert's disease or Dubin-Johnson disease Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration) Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1 week prior to the start of study drug administration and for the duration of the study Any other sound medical, psychiatric, and/or social reason as determined by the investigator
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ViiV Clinical Trials, MD
    Organizational Affiliation
    ViiV Healthcare
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study on Pharmacokinetics

    We'll reach out to this number within 24 hrs