Study on Pharmacokinetics

NCT ID: NCT02234882

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-05
• Study Completion Date: 2014-10-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Rosuvastatin and 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

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

BMS-663068

Intervention Type: DRUG

Interventions

Rosuvastatin

Intervention Type: DRUG

BMS-663068

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ViiV Clinical Trials, MD

Role: STUDY_DIRECTOR

ViiV Healthcare

Other Identifiers

AI438-048

Identifier Type: OTHER

Identifier Source: secondary_id

206276

Identifier Type: -

Identifier Source: org_study_id