NCT03306667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 20, 2017

Last Update Submit

September 21, 2018

Conditions

Hepatic InsufficiencyHealthy

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (4)

Normal group

EXPERIMENTAL

Healthy control subjects

Drug: FYU-981

Mild hepatic-insufficient group

EXPERIMENTAL

Patients with mild hepatic impaired function (Child-Pugh A)

Drug: FYU-981

Moderate hepatic-insufficient group

EXPERIMENTAL

Patients with moderate hepatic impaired function (Child-Pugh B)

Drug: FYU-981

Severe hepatic-insufficient group

EXPERIMENTAL

Patients with severe hepatic impaired function (Child-Pugh C)

Drug: FYU-981

Interventions

FYU-981DRUG

Oral single dosing

Mild hepatic-insufficient groupModerate hepatic-insufficient groupNormal groupSevere hepatic-insufficient group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mochida Investigational sites

Tokyo, Japan

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

dotinurad

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Shigeki Matsumoto

    Clinical Research Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

October 11, 2017

Study Start

October 6, 2017

Primary Completion

June 20, 2018

Study Completion

June 25, 2018

Last Updated

September 24, 2018

Record last verified: 2018-09

Locations

JP(1)