Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Phase 1 Completed 26 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedSequentialOpen-labelOther

Summary

The purpose of this study is to characterize the effect of repeated oral administration of TAK-788 160 milligram (mg) once daily on the single oral and intravenous dose pharmacokinetics (PK) of midazolam.

Timeline

Start: 2019-12-23
Primary completion: 2020-12-17
Completion: 2021-12-07

Publications

Hanley MJ, Zhang S, Pavlakis N, Soo RA, van der Wekken AJ, Ganju V, Pina A, Dong Q, Gupta N. A Drug-Drug Interaction Study of Mobocertinib and Midazolam, a Cytochrome P450 3A Substrate, in Patients With Advanced Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2025 Mar;14(3):252-262. doi: 10.1002/cpdd.1500. Epub 2025 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	1 mg	Oral
Subject	Midazolam	Small molecule	3 mg	Oral
Subject	Mobocertinib	Small molecule	160 mg	Oral

Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Summary

Timeline

Publications

Drugs

Indications