Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment

Phase 1 Completed 32 enrolled AstraZeneca PRA Health Sciences · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and weight. As for all clinical trials, safety and tolerability of the drug will be evaluated as well to develop dosing recommendations for dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.

Timeline

Start: 2008-04
Primary completion: —
Completion: 2009-03

Publications

Tomkinson H, Kemp J, Oliver S, Swaisland H, Taboada M, Morris T. Pharmacokinetics and tolerability of zibotentan (ZD4054) in subjects with hepatic or renal impairment: two open-label comparative studies. BMC Clin Pharmacol. 2011 Mar 17;11:3. doi: 10.1186/1472-6904-11-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zibotentan	Small molecule	10 mg	Oral

Indications

No indication recorded.