NCT03375632

Brief Summary

To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

December 10, 2017

Last Update Submit

September 21, 2018

Conditions

Hyperuricemia With or Without Gout

Outcome Measures

Primary Outcomes (4)

  • Pharmacodynamics (Amount of uric acid excreted in urine)

    2-week

  • Pharmacodynamics (Amount of uric acid excreted in urine)

    6-week

  • Pharmacodynamics (Amount of uric acid excreted in urine)

    10-week

  • Pharmacodynamics (Amount of uric acid excreted in urine)

    14-week

Study Arms (2)

Uric acid-overproduction Type

EXPERIMENTAL
Drug: FYU-981

Uric acid-underexcretion Type

EXPERIMENTAL
Drug: FYU-981

Interventions

FYU-981DRUG

Oral daily dosing for 14 weeks

Uric acid-overproduction TypeUric acid-underexcretion Type

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serum urate level:
  • \>= 7.0mg/dL in patients with gouty nodule or with history of gout, or \>=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL
  • Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
  • Outpatients

You may not qualify if:

  • Gouty arthritis within 14 days before randomized allocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mochida Investigational sites

Tokyo, Japan

Location

MeSH Terms

Interventions

dotinurad

Study Officials

  • Kazuki Furuno

    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

December 10, 2017

First Posted

December 18, 2017

Study Start

January 4, 2018

Primary Completion

May 29, 2018

Study Completion

June 5, 2018

Last Updated

September 24, 2018

Record last verified: 2018-09

Locations

JP(1)