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Study of Telaprevir in Subjects With Hepatic Impairment

Phase 1
Completed
Conditions
Hepatic Insufficiency
Registration Number
NCT00509210
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Brief Summary

The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Clinically diagnosed with Child Pugh score of 7-9 or greater than 10
  • Women of non-childbearing age
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Exclusion Criteria
  • Tested positive for HIV, Hepatitis C, Hepatitis B
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Pharmacokinetics
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology

🇺🇸

Indianapolis, Indiana, United States

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