A Study to Assess Safety and Pharmacokinetics of Telaprevir in Patients With Hepatic Impairment

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the pharmacokinetic (what the body does to the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment, compared to the pharmacokinetic parameters in patients with normal liver function, and measure the relative unbound plasma concentrations of telaprevir.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Infectious Diseases BVBA

Criteria

Inclusion Criteria:

For Group 1:

• Moderate liver function impairment (Child Pugh score of 7 to 9)

• History of hepatic disease, such as hepatitis B, previous hepatitis C, alcoholic liver disease, autoimmune hepatitis, non-alcoholic fatty liver disease, hereditary/metabolic, cryptogenic, other

• Consistent with the disease process of hepatic impairment and associated symptoms

For Group 2:

• Matched to a patient with moderate hepatic impairment with regards to sex, age (± 5 years), and BMI (± 15%) and healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality

For Group 3:

• Severe liver function impairment (limited to Child Pugh score of 10 to 12)

• Hepatic impairment due to different etiologies such as hepatitis B, previous hepatitis C, alcoholic liver disease, autoimmune hepatitis, non-alcoholic fatty liver disease, hereditary/metabolic, cryptogenic, other

• Consistent with the disease process of hepatic impairment and associated symptoms

Exclusion Criteria:

For Group 1 and 3:

• Has acute infectious hepatitis

• Has grade 3 or 4 encephalopathy

• Has grade 3 or 4 creatinine elevation

• Is an active candidate for liver transplantation

• Has had variceal bleeding or spontaneous bacterial peritonitis

For Group 1 only:

• Has a porta-caval shunt or transjugular intrahepatic porto-systemic shunts

For Group 2:

Has acute hepatitis A or hepatitis B or hepatitis C infection