Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects

Phase 2 Completed 23 enrolled Taisho Pharmaceutical Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants

Timeline

Start: 2019-09-17
Primary completion: 2019-11-30
Completion: 2019-11-30

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	vornorexant	Unknown	20 mg	—

Indications

No indication recorded.