Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Mochida Investigational sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult healthy subjects or adult cirrhosis patients
• Body mass index: >=18.5 and <30.0

Exclusion Criteria:

• Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal group; Healthy control subjects	Drug: FYU-981; Oral single dosing
Experimental: Mild hepatic-insufficient group; Patients with mild hepatic impaired function (Child-Pugh A)	Drug: FYU-981; Oral single dosing
Experimental: Moderate hepatic-insufficient group; Patients with moderate hepatic impaired function (Child-Pugh B)	Drug: FYU-981; Oral single dosing
Experimental: Severe hepatic-insufficient group; Patients with severe hepatic impaired function (Child-Pugh C)	Drug: FYU-981; Oral single dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (Cmax: Maximum plasma concentration)	48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)	48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)	48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)	48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)	48 hours
Pharmacokinetics (kel: Elimination rate constant)	48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)	48 hours
Pharmacokinetics (MRT: Mean residence time)	48 hours
Pharmacodynamics (Serum concentration of uric acid)	48 hours
Pharmacodynamics (Amount of uric acid excreted in urine)	48 hours
Safety (Incidence of treatment-emergent adverse events)	192 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Antirheumatic Agents; Gout Suppressants; Renal Agents; Uricosuric Agents; Dotinurad
• Other Study ID Numbers: FYU-981-015

Drug and device information, study documents

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