Study on Pharmacokinetics

Study Overview
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Brief Summary
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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.

Official Title
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Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: BMS-663068


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin and BMS-663068<br>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<br> <br> Drug: BMS-663068<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of rosuvastatin |  | Days 1 through 13 | 
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin |  | Days 1 through 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough blood samples of BMS-626529 concentration |  | Days 7 through 13 | 
| Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. |  | 40 days |