Completed
PHASE1
INTERVENTIONAL
NCT01038167
A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults
View on ClinicalTrials.gov
Updated Dec 15, 2025
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
Name:
telaprevir
Type:
DRUG
Description:
Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2
Name:
telaprevir
Type:
DRUG
Description:
Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2
Name:
cyclosporine
Type:
DRUG
Description:
Solution, Oral, 100mg, Day 1 of Period 1
Name:
cyclosporine
Type:
DRUG
Description:
Solution, Oral, 10mg, Day 1 and Day 8 of Period 2
Name:
tacrolimus
Type:
DRUG
Description:
Capsule, Oral, 2mg, Day 1 of Period 1
Name:
tacrolimus
Type:
DRUG
Description:
Capsule, Oral, 0.5mg, Day 8 of Period 2
Primary Outcomes
Measure:
Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)
TimeFrame:
33 days
Description:
Measure:
Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)
TimeFrame:
33 days for Part A; 44 days for Part B
Description:
Measure:
Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)
TimeFrame:
44 days
Description:
Trial Information
NCT ID
NCT01038167
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Vertex Pharmaceuticals Incorporated
Last Updated
December 15, 2025