Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

Phase 1 Completed 28 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

Timeline

Start: 2015-12-04
Primary completion: 2016-12-08
Completion: 2016-12-08

Publications

Morcos PN, Cleary Y, Sturm-Pellanda C, Guerini E, Abt M, Donzelli M, Vazvaei F, Balas B, Parrott N, Yu L. Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib. J Clin Pharmacol. 2018 Dec;58(12):1618-1628. doi: 10.1002/jcph.1286. Epub 2018 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alectinib	Small molecule	300 mg	Oral

Indications

No indication recorded.