A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants

Phase 1 Terminated 32 enrolled Millennium Pharmaceuticals, Inc.

RandomizedSequentialTriple-blindOther

Summary

The purpose of this study is to characterize safety and tolerability of TAK-418 in non-Japanese and Japanese healthy female participants when administered at single or multiple (once daily \[QD\]) oral doses.

Timeline

Start: 2018-05-30
Primary completion: 2018-12-26
Completion: 2018-12-26

Outcome

Outcome not reported

Stopped (Business): “Business Decision; no human safety concern; evaluating preclinical toxicology finding”

Publications

Yin W, Arkilo D, Khudyakov P, Hazel J, Gupta S, Quinton MS, Lin J, Hartman DS, Bednar MM, Rosen L, Wendland JR. Safety, pharmacokinetics and pharmacodynamics of TAK-418, a novel inhibitor of the epigenetic modulator lysine-specific demethylase 1A. Br J Clin Pharmacol. 2021 Dec;87(12):4756-4768. doi: 10.1111/bcp.14912. Epub 2021 Jun 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TAK-418	Small molecule	20 mg	Oral
Subject	TAK-418	Small molecule	40 mg	Oral
Subject	TAK-418	Small molecule	60 mg	Oral
Subject	TAK-418	Small molecule	120 mg	Oral
Subject	TAK-418	Small molecule	160 mg	Oral

Indications

No indication recorded.