Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Participants

Phase 1 Completed 60 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438 following multiple oral doses to healthy adult Japanese male participants

Timeline

Start: 2008-10
Primary completion: 2009-03
Completion: 2009-03

Publications

Jenkins H, Sakurai Y, Nishimura A, Okamoto H, Hibberd M, Jenkins R, Yoneyama T, Ashida K, Ogama Y, Warrington S. Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015 Apr;41(7):636-48. doi: 10.1111/apt.13121. Epub 2015 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vonoprazan	Other / unclassified	10 mg	Oral
Subject	Vonoprazan	Other / unclassified	15 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral
Subject	Vonoprazan	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	40 mg	Oral

Indications

No indication recorded.