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Completed

NCT Number: NCT03375632

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

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.

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Key information

Conditions

Hyperuricemia With or Without Gout

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mochida Investigational sites

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FYU-981

Drug

Oral daily dosing for 14 weeks

Primary outcomes

  1. Pharmacodynamics (Amount of uric acid excreted in urine)

    Time frame: 2-week

  2. Pharmacodynamics (Amount of uric acid excreted in urine)

    Time frame: 6-week

  3. Pharmacodynamics (Amount of uric acid excreted in urine)

    Time frame: 10-week

  4. Pharmacodynamics (Amount of uric acid excreted in urine)

    Time frame: 14-week

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Collaborators

  • Fuji Yakuhin Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 18, 2017
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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