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

Phase 1

Completed

• Conditions: Hepatic Insufficiency; Healthy
• Interventions: Drug: FYU-981

• Registration Number: NCT03306667
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-10-05
• Study Start: 2017-10-06
• Study First Posted: 2017-10-11
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe hepatic-insufficient group	FYU-981	Patients with severe hepatic impaired function (Child-Pugh C)
Normal group	FYU-981	Healthy control subjects
Mild hepatic-insufficient group	FYU-981	Patients with mild hepatic impaired function (Child-Pugh A)
Moderate hepatic-insufficient group	FYU-981	Patients with moderate hepatic impaired function (Child-Pugh B)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mochida Investigational sites; 🇯🇵 Tokyo, Japan