Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

NCT ID: NCT02837198

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-03-31

Brief Summary

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To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type.

In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.

Detailed Description

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Conditions

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Hyperuricemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Uric acid-overproduction Type

FYU-981

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Uric acid- underexcretion Type

FYU-981

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Uric acid-overproduction Type (combination)

FYU-981 , Topiroxostat

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Topiroxostat

Intervention Type DRUG

Uric acid- underexcretion Type2

FYU-981

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Interventions

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FYU-981

Intervention Type DRUG

Topiroxostat

Intervention Type DRUG

Other Intervention Names

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FYX-051

Eligibility Criteria

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Inclusion Criteria

* Japanese adult subjects
* Serum urate level: \>= 7.0mg/dL in patients
* Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type

Exclusion Criteria

* Gouty arthritis within a year before start of study treatment
* Mixed type in the classification of hyperuricemia
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fuji Yakuhin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

References

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Okui D, Sasaki T, Fushimi M, Ohashi T. The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):92-102. doi: 10.1007/s10157-019-01817-3. Epub 2019 Nov 16.

Reference Type DERIVED
PMID: 31734820 (View on PubMed)

Other Identifiers

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FYU-981-008

Identifier Type: -

Identifier Source: org_study_id

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