Study on Pharmacokinetics

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Rosuvastatin; Drug: BMS-663068

• Registration Number: NCT02234882
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-05
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin and BMS-663068	BMS-663068	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
Rosuvastatin and BMS-663068	Rosuvastatin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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