drugset

drugset / Trial / NCT03865446

Evaluate Severe Hepatic Impairment on Dacomitinib PK

NCT03865446 ↗

Phase 1 Completed 16 enrolled Pfizer

Non-randomizedParallel-groupOpen-labelOther

Summary

This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.

Timeline

Start: 2019-04-05
Primary completion: 2019-10-24
Completion: 2019-10-24

Publications

Piscitelli J, Chen J, LaBadie RR, Salageanu J, Chung CH, Tan W. The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib. Clin Drug Investig. 2022 Mar;42(3):221-235. doi: 10.1007/s40261-022-01125-x. Epub 2022 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DACOMITINIB ANHYDROUS	Small molecule	30 mg	Oral

Indications

No indication recorded.