Afatinib in Subjects With Kidney Dysfunction

Summary

The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function. The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.

Timeline

Start

2014-05

Primary completion

2014-12

Completion

2014-12

Publications

• Wiebe S, Schnell D, Kulzer R, Gansser D, Weber A, Wallenstein G, Halabi A, Conrad A, Wind S. Influence of Renal Impairment on the Pharmacokinetics of Afatinib: An Open-Label, Single-Dose Study. Eur J Drug Metab Pharmacokinet. 2017 Jun;42(3):461-469. doi: 10.1007/s13318-016-0359-9.

Drugs

Indications