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

August 20, 2018 updated by: Fuji Yakuhin Co., Ltd.

Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Uric acid-overproduction Type
FYU-981
Drug: FYU-981
Experimental: Uric acid- underexcretion Type
FYU-981
Drug: FYU-981
Experimental: Uric acid-overproduction Type (combination)
FYU-981 , Topiroxostat
Drug: FYU-981
Drug: Topiroxostat
Other Names:
  • FYX-051
Experimental: Uric acid- underexcretion Type2
FYU-981
Drug: FYU-981

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
Pharmacodynamics (Renal clearance of uric acid)
Time Frame: 1-, 4- and 7-day
1-, 4- and 7-day
Pharmacodynamics (Fractional uric acid excretion)
Time Frame: 4- and 7-day
4- and 7-day
Pharmacodynamics (Maximum delta effective uric acid concentration)
Time Frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
Time Frame: 1-, 4- and 7-day
1-, 4- and 7-day

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmin: Minimum plasma concentration)
Time Frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 1-, and 7-day
1-, and 7-day
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 1-, and 7-day
1-, and 7-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuji Yakuhin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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