A Pharmacokinetic Study of Narlaprevir as a Single Dose or With Ritonavir Combination in Patients With Hepatic Impairment and Healthy Matched Volunteers

Phase 1 Completed 32 enrolled R-Pharm Ascent · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study was conducted to evaluate narlaprevir (NVR) pharmacokinetics (PK) after a single dose with or without ritonavir (RTV) in cirrhotic Child-Pugh class A patients without active HCV infection versus healthy subjects as well as to assess safety and tolerability of such treatment combination.

Timeline

Start: 2013-11-08
Primary completion: 2014-10-24
Completion: 2014-10-24

Publications

Results Isakov V, Koloda D, Tikhonova N, Kikalishvili T, Krasavina E, Lekishvili K, Malaya I, Ryska M, Samsonov M, Tolkacheva V. Pharmacokinetics of the New Hepatitis C Virus NS3 Protease Inhibitor Narlaprevir following Single-Dose Use with or without Ritonavir in Patients with Liver Cirrhosis. Antimicrob Agents Chemother. 2016 Nov 21;60(12):7098-7104. doi: 10.1128/AAC.01044-16. Print 2016 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Narlaprevir	Small molecule	100 mg	Oral
Subject	Narlaprevir	Small molecule	200 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	—

Indications

No indication recorded.