Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

Summary

The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.

Timeline

Start

2014-07

Primary completion

2014-12

Completion

2015-01

Drugs

Indications