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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part A

Part A will be administered in two periods, separated by a washout. In Period 1, subjects will receive cyclosporine alone. In Period 2, subjects will receive cyclosporine in combination with telaprevir.

Group Type EXPERIMENTAL

telaprevir

Intervention Type DRUG

Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2

cyclosporine

Intervention Type DRUG

Solution, Oral, 100mg, Day 1 of Period 1

cyclosporine

Intervention Type DRUG

Solution, Oral, 10mg, Day 1 and Day 8 of Period 2

Part B

Part B will be administered in two periods, separated by a washout. In Period 1, subjects will receive tacrolimus alone. In Period 2, subjects will receive tacrolimus in combination with telaprevir.

Group Type EXPERIMENTAL

telaprevir

Intervention Type DRUG

Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2

tacrolimus

Intervention Type DRUG

Capsule, Oral, 2mg, Day 1 of Period 1

tacrolimus

Intervention Type DRUG

Capsule, Oral, 0.5mg, Day 8 of Period 2

Interventions

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telaprevir

Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2

Intervention Type DRUG

telaprevir

Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2

Intervention Type DRUG

cyclosporine

Solution, Oral, 100mg, Day 1 of Period 1

Intervention Type DRUG

cyclosporine

Solution, Oral, 10mg, Day 1 and Day 8 of Period 2

Intervention Type DRUG

tacrolimus

Capsule, Oral, 2mg, Day 1 of Period 1

Intervention Type DRUG

tacrolimus

Capsule, Oral, 0.5mg, Day 8 of Period 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes