drugset / Trial / NCT01197911

A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar

NCT01197911

Phase 1 Completed 38 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-label

Summary

This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.

Timeline

Start
2010-09
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject aleglitazar Small molecule Oral

Indications

No indication recorded.