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

NCT01511432 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2012-07-04

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT01511432 on ClinicalTrials.gov