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

NCT01038167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-04-08

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

telaprevir

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

DRUG

telaprevir

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

DRUG

cyclosporine

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

DRUG

cyclosporine

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

DRUG

tacrolimus

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

DRUG

tacrolimus

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038167 on ClinicalTrials.gov