NCT01511432

A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects

A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	telaprevir formulation A	A single 1125-mg dose administered orally
DRUG	telaprevir Formulation B	A single 1125-mg dose administered orally
DRUG	telaprevir Formulation C	A single 1125-mg dose administered orally
DRUG	telaprevir Formulation D	A single 1125-mg dose administered orally

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2012-01-18
• Last updated: 2012-07-04

Locations

2 sites across 1 country: United States