Study on Pharmacokinetics

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: BMS-663068; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02234882

AI438-048 (Other Identifier)

206276

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Rosuvastatin and BMS-663068

Experimental group

Description:

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

Treatment:

Drug: BMS-663068

Drug: Rosuvastatin