A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

Phase 1 Completed 16 enrolled Pfizer

Open-labelBasic science

Summary

The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.

Timeline

Start: 2016-08-16
Primary completion: 2017-03-31
Completion: 2017-05-03

Publications

Patel M, Chen J, McGrory S, O'Gorman M, Nepal S, Ginman K, Pithavala YK. The effect of itraconazole on the pharmacokinetics of lorlatinib: results of a phase I, open-label, crossover study in healthy participants. Invest New Drugs. 2020 Feb;38(1):131-139. doi: 10.1007/s10637-019-00872-7. Epub 2019 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Lorlatinib	Small molecule	50 mg	Oral
Subject	Lorlatinib	Small molecule	75 mg	Oral
Subject	Lorlatinib	Small molecule	100 mg	Oral

Indications

No indication recorded.