Study on Pharmacokinetics

HIV Infections Clinical Trial

Official title:

Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234882
• Other study ID #: 206276
• Secondary ID: AI438-048
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2014
• Last updated: April 13, 2018
• Start date: September 5, 2014
• Est. completion date: October 31, 2014

Study information

• Verified date: April 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Rosuvastatin

• BMS-663068

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of rosuvastatin		Days 1 through 13
Primary	Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin		Days 1 through 13
Secondary	Trough blood samples of BMS-626529 concentration		Days 7 through 13
Secondary	Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.		40 days