Status:
COMPLETED
Study on Pharmacokinetics
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02234882
Start Date
September 5 2014
End Date
October 31 2014
Last Update
April 17 2018
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