Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

Phase 1 Completed 40 enrolled Taisho Pharmaceutical Co., Ltd.

RandomizedSequentialQuadruple-blindBasic science

Summary

To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.

Timeline

Start: 2015-12-24
Primary completion: 2016-04-14
Completion: 2016-04-14

Publications

Results Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TS-143	Unknown	3 mg	Oral
Subject	TS-143	Unknown	6 mg	Oral
Subject	TS-143	Unknown	11 mg	Oral
Subject	TS-143	Unknown	20 mg	Oral
Subject	TS-143	Unknown	36 mg	Oral

Indications

No indication recorded.