Clinical Trials

MainTitle

Study on Pharmacokinetics

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02234882

First received: September 5, 2014
Last updated: April 13, 2018
Last Verified: April 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Rosuvastatin
Drug : BMS-663068
Phase 1

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Maximum observed plasma concentration (Cmax) of rosuvastatin [ Time Frame: Days 1 through 13 ]
  • 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 Measures:
  • Trough blood samples of BMS-626529 concentration [ Time Frame: Days 7 through 13 ]
  • Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: 40 days ]

Enrollment: 50
Study Start Date: September 5, 2014
Study Completion Date: October 31, 2014
Primary Completion Date: October 31, 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Rosuvastatin and BMS-663068
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
Drug: Rosuvastatin
Drug: BMS-663068
Eligibility

Eligibility

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

Criteria

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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02234882

    Sponsors and Collaborators

    ViiV Healthcare
    GlaxoSmithKline

    Investigators

    Study Director: ViiV Clinical Trials, MD ViiV Healthcare
    More Information

    More Information


    Responsible Party: ViiV Healthcare  
    ClinicalTrials.gov Identifier: NCT02234882   History of Changes  
    Other Study ID Numbers: 206276  
      AI438-048  
    Study First Received: September 5, 2014  
    Last Updated: April 13, 2018  

    Additional relevant MeSH terms:
    HIV Infections
    Rosuvastatin Calcium

    ClinicalTrials.gov processed this data on June 02, 2020
    This information is provided by ClinicalTrials.gov.