Clinical Pharmacology of FYU-981 (Final Formulation)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: FYU-981

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachiōji, Tokyo, Japan, 192-0071
      • P-One Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Japanese healthy adult subjects
• Body mass index: >=18.5 and <25.0

Exclusion Criteria:

• Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasted dosing followed by fed dosing; Dosing of FYU-981 in the fasted state followed by fed dosing	Drug: FYU-981; Single administration of FYU-981 under Fasted and fed conditions in the morning.; Other Names: Final formulation of FYU-981
Experimental: Fed dosing followed by fasted dosing; Dosing of FYU-981 in the fed state followed by fasted dosing	Drug: FYU-981; Single administration of FYU-981 under Fasted and fed conditions in the morning.; Other Names: Final formulation of FYU-981

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (Cmax: Maximum plasma concentration)		48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)		48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)		48 hours
Pharmacokinetics (kel: Elimination rate constant)		48 hours
Pharmacokinetics (MRT: Mean residence time)		48 hours
Pharmacokinetics	T1/2: Elimination half-life of plasma concentration	48 hours
Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed)		48 hours
Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed)		48 hours
Safety (Incidence of treatment-emergent adverse events)		13 days

Collaborators and Investigators

• Sponsor: Mochida Pharmaceutical Company, Ltd.
• Collaborators: Fuji Yakuhin Co., Ltd.
• Investigators: Study Director: Katsuaki Nagasawa, Clinical Research Department

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 19, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Renal Agents; Uricosuric Agents; Dotinurad
• Other Study ID Numbers: FYU-981-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No