Hepatic Insufficiency
Conditions
Keywords
Liver Disease
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.
Interventions
DRUGtelaprevir (VX-950)
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed with Child Pugh score of 7-9 or greater than 10 * Women of non-childbearing age
Exclusion criteria
* Tested positive for HIV, Hepatitis C, Hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Countries
United States
Outcome results
None listed