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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: telaprevir; Drug: cyclosporine; Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01038167

VX09-950-021

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Part A

Experimental group

Description:

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.

Treatment:

Drug: telaprevir

Drug: cyclosporine

Drug: cyclosporine

Drug: telaprevir

Part B

Experimental group

Description:

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.

Treatment:

Drug: tacrolimus

Drug: tacrolimus

Drug: telaprevir

Drug: telaprevir