Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

Phase 2 Completed 24 enrolled Fuji Yakuhin Co., Ltd.

Non-randomizedParallel-groupOpen-labelBasic science

Summary

To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type. In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.

Timeline

Start: 2016-07
Primary completion: 2017-08
Completion: 2018-03

Publications

Okui D, Sasaki T, Fushimi M, Ohashi T. The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):92-102. doi: 10.1007/s10157-019-01817-3. Epub 2019 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dotinurad	Small molecule	1 mg	Oral
Subject	Topiroxostat	Small molecule	80 mg	Oral

Indications

No indication recorded.