A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects

Phase 1 Completed 36 enrolled Pfizer

RandomizedCrossoverDouble-blindBasic science

Summary

This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects. This is a randomized, double blind, positive and placebo controlled study with a 6 day washout between successive periods.

Timeline

Start: 2017-06-09
Primary completion: 2017-09-23
Completion: 2017-10-16

Publications

Masters JC, Shaik N, Mendes da Costa L, Hee B, LaBadie RR. Clinical and Model-Based Evaluation of the Effect of Glasdegib on Cardiac Repolarization From a Randomized Thorough QT Study. Clin Pharmacol Drug Dev. 2021 Mar;10(3):272-282. doi: 10.1002/cpdd.862. Epub 2020 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glasdegib	Small molecule	150 mg	Oral
Subject	Glasdegib	Small molecule	300 mg	Oral
Subject	Moxifloxacin	Small molecule	400 mg	—

Indications

No indication recorded.