drugset / Trial / NCT02348333

Repeated Dose Phase I Study of FYU-981

NCT02348333

Phase 1 Completed 18 enrolled Fuji Yakuhin Co., Ltd.
RandomizedParallel-groupQuadruple-blindBasic science

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.

Timeline

Start
2013-09
Primary completion
2013-11
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dotinurad Small molecule Oral

Indications

No indication recorded.