drugset / Trial / NCT01298063

Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

NCT01298063

Phase 1 Completed 35 enrolled Boehringer Ingelheim
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.

Timeline

Start
2011-02
Primary completion
2012-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule

Indications