A Phase I Study of TS-142 in Healthy Participants (Single Doses)

Phase 1 Completed 32 enrolled Taisho Pharmaceutical Co., Ltd.

RandomizedSequentialTriple-blindTreatment

Summary

The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.

Timeline

Start: 2015-10-17
Primary completion: 2016-02-06
Completion: 2016-02-06

Publications

Results Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TS-142	Small molecule	1 mg	—
Subject	TS-142	Small molecule	3 mg	—
Subject	TS-142	Small molecule	10 mg	—
Subject	TS-142	Small molecule	30 mg	—

Indications

No indication recorded.