NCT01038167

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-12-23
• Last updated: 2010-04-08

Locations

1 site across 1 country: United States