A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants

Phase 1 Completed 24 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedSequentialOpen-labelOther

Summary

The purpose of this study is to characterize the effect of itraconazole (Part 1) and rifampin (Part 2) on the single-dose pharmacokinetics (PK) of TAK-788 and its active metabolites (AP32960 and AP32914) in healthy adult participants.

Timeline

Start: 2019-05-02
Primary completion: 2019-08-16
Completion: 2019-08-16

Publications

Zhang S, Jin S, Griffin C, Feng Z, Lin J, Venkatakrishnan K, Gupta N. Effects of Itraconazole and Rifampin on the Pharmacokinetics of Mobocertinib (TAK-788), an Oral Epidermal Growth Factor Receptor Inhibitor, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1044-1053. doi: 10.1002/cpdd.967. Epub 2021 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Mobocertinib	Small molecule	20 mg	Oral
Subject	Mobocertinib	Small molecule	160 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral

Indications

No indication recorded.