A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib

Phase 1 Completed 24 enrolled Pfizer

RandomizedParallel-groupOpen-labelBasic science

Summary

This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.

Timeline

Start: 2018-11-05
Primary completion: 2019-04-11
Completion: 2019-04-11

Publications

Masters JC, LaBadie RR, Salageanu J, Li J, Shaik N. Pharmacokinetics and Safety of Glasdegib in Participants With Moderate/Severe Hepatic Impairment: A Phase I, Single-Dose, Matched Case-Control Study. Clin Pharmacol Drug Dev. 2021 Jul;10(7):707-717. doi: 10.1002/cpdd.897. Epub 2020 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glasdegib	Small molecule	100 mg	Oral

Indications

No indication recorded.