NCT02348307

Single Dose Phase I Study of FYU-981

Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Fuji Yakuhin Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. 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. The effect of food on PK/PD of FYU-981 is also investigated.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FYU-981, (Oral single dosing)	Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
DRUG	Placebo, (Oral single dosing)	Subjects randomized to the placebo arm receive placebo.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2015-01-28
• Last updated: 2015-01-28

Locations

1 site across 1 country: Japan