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

Phase 1 Completed 24 enrolled Janssen Infectious Diseases BVBA

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2012-06
Primary completion: 2012-10
Completion: 2012-11

Publications

Ouwerkerk-Mahadevan S, Halabi A, Cieslarova B, Aerts I, Witek J, Van Solingen-Ristea R, Luo D. Pharmacokinetics of bound and unbound telaprevir in cirrhotic patients with moderate and severe hepatic impairment. J Clin Pharmacol. 2015 Oct;55(10):1147-56. doi: 10.1002/jcph.545. Epub 2015 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telaprevir	Small molecule	750 mg	Oral

Indications

No indication recorded.