Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03375632

Enrollment

Registered

2017-12-18

Start date

2018-01-04

Completion date

2018-06-05

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia With or Without Gout

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.

Interventions

DRUGFYU-981

Oral daily dosing for 14 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Gouty arthritis within 14 days before randomized allocation

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics (Amount of uric acid excreted in urine)	2-week

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026