HIV Infections
Conditions
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.
Interventions
DRUGRosuvastatin
DRUGBMS-663068
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed