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

An Open-Label Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01038167

Enrollment

Registered

2009-12-23

Start date

2010-01-31

Completion date

2010-04-30

Last updated

2010-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

VX-950

Brief summary

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.

Interventions

DRUGtelaprevir

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

DRUGcyclosporine

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

DRUGtacrolimus

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)	33 days
Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)	33 days for Part A; 44 days for Part B
Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)	44 days

Secondary

Measure	Time frame
Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations	33 days for Part A; 44 days for Part B

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026