TAK-438_110 Drug Interaction With Cytochrome P450 3A4 (CYP3A4) Inhibitor Clarithromycin

Phase 1 Completed 16 enrolled Takeda

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants following a single oral dose of TAK-438.

Timeline

Start: 2010-08
Primary completion: 2010-09
Completion: 2010-09

Publications

Jenkins H, Jenkins R, Patat A. Effect of Multiple Oral Doses of the Potent CYP3A4 Inhibitor Clarithromycin on the Pharmacokinetics of a Single Oral Dose of Vonoprazan: A Phase I, Open-Label, Sequential Design Study. Clin Drug Investig. 2017 Mar;37(3):311-316. doi: 10.1007/s40261-016-0488-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clarithromycin	Small molecule	500 mg	Oral
Subject	Vonoprazan	Other / unclassified	40 mg	Oral

Indications

No indication recorded.