Study on Pharmacokinetics

• Status: Completed
• Trial end date: 2014-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Fostemsavir; Rosuvastatin Calcium

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