Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011

Phase 1 Completed 30 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.

Timeline

Start: 2015-03-25
Primary completion: 2017-01-09
Completion: 2017-01-09

Publications

Samant TS, Yang S, Miller M, Ji Y. Pharmacokinetics of Ribociclib in Subjects With Hepatic Impairment. J Clin Pharmacol. 2021 Aug;61(8):1001-1009. doi: 10.1002/jcph.1825. Epub 2021 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ribociclib	Small molecule	400 mg	Oral

Indications

No indication recorded.