A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants

Phase 1 Completed 26 enrolled Eisai Inc.

Non-randomizedParallel-groupOpen-labelBasic science

Summary

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad following single and multiple oral doses of dotinurad in Chinese healthy male and female participants.

Timeline

Start: 2022-07-01
Primary completion: 2022-12-13
Completion: 2022-12-13

Publications

Liu Y, Chen Q, Sun H, Cai C, Kawamura K, Kokan R, Nomoto M. A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults. Clin Drug Investig. 2025 Dec;45(12):957-966. doi: 10.1007/s40261-025-01496-x. Epub 2025 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dotinurad	Small molecule	1 mg	Oral
Subject	Dotinurad	Small molecule	4 mg	Oral
Subject	Dotinurad	Small molecule	10 mg	Oral

Indications

No indication recorded.