A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults

Completed · Phase 1

Conditions studied: Hepatitis C

In brief

The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Key facts

Study ID

NCT01038167

Run by

Vertex Pharmaceuticals Incorporated

People needed

20

Starts

2010-01-01

Expected to finish

2010-04-01

Last updated by the study team

2010-04-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive)
• Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening.

You may not qualify if…

• History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
• Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit.
• Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.

Where it is running

• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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