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OpenTrials
Completed

NCT Number: NCT02234882

Study on Pharmacokinetics

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Rosuvastatin

Drug

BMS-663068

Drug

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of rosuvastatin

    Time frame: Days 1 through 13

  2. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin

    Time frame: Days 1 through 13

Secondary outcomes

  1. Trough blood samples of BMS-626529 concentration

    Time frame: Days 7 through 13

  2. Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

    Time frame: 40 days

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2014
Registry last updated
Apr 17, 2018

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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