Influence of mild and moderate hepatic impairment on axitinib pharmacokinetics.

ABSTRACT:

Objective

To evaluate the effects of hepatic impairment on the pharmacokinetics and safety of a single, oral axitinib dose in subjects with mild or moderate hepatic impairment.

Methods

In this phase I, open-label, parallel-group study, a total of 24 subjects with either normal hepatic function (n = 8) or with mild (n = 8) or moderate (n = 8) hepatic impairment were administered a single, oral dose of axitinib (5 mg). Blood samples were collected at intervals up to 144 h following dosing, and plasma pharmacokinetics and safety were assessed. Changes in axitinib plasma exposures in subjects with mild or moderate hepatic impairment were predicted using computer simulations and used to guide initial dosing in the clinical study.

Results

Axitinib exposure was similar in su

SUBMITTER: Tortorici MA 

PROVIDER: S-EPMC3171651 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature