NCT03350373

Clinical Pharmacology of FYU-981 (Final Formulation)

Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mochida Pharmaceutical Company, Ltd. · Industry
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FYU-981	Single administration of FYU-981 under Fasted and fed conditions in the morning.

Timeline

• Start date: 2017-11-06
• Primary completion: 2017-11-29
• Completion: 2017-11-29
• First posted: 2017-11-22
• Last updated: 2017-12-12

Locations

1 site across 1 country: Japan