NCT02837198

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

July 15, 2016

Last Update Submit

August 20, 2018

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (5)

  • Pharmacodynamics (Amount of uric acid excreted in urine)

    1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day

  • Pharmacodynamics (Renal clearance of uric acid)

    1-, 4- and 7-day

  • Pharmacodynamics (Fractional uric acid excretion)

    4- and 7-day

  • Pharmacodynamics (Maximum delta effective uric acid concentration)

    1-, 2-, 3-, 4-, 5-, 6- and 7-day

  • Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)

    1-, 4- and 7-day

Secondary Outcomes (9)

  • Pharmacokinetics (Cmax: Maximum plasma concentration)

    1-, and 7-day

  • Pharmacokinetics (Cmin: Minimum plasma concentration)

    1-, 2-, 3-, 4-, 5-, 6- and 7-day

  • Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)

    1-, and 7-day

  • Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)

    1-, and 7-day

  • Pharmacokinetics (AUC: Area under the plasma concentration-time curve)

    1-, and 7-day

  • +4 more secondary outcomes

Study Arms (4)

Uric acid-overproduction Type

EXPERIMENTAL

FYU-981

Drug: FYU-981

Uric acid- underexcretion Type

EXPERIMENTAL

FYU-981

Drug: FYU-981

Uric acid-overproduction Type (combination)

EXPERIMENTAL

FYU-981 , Topiroxostat

Drug: FYU-981Drug: Topiroxostat

Uric acid- underexcretion Type2

EXPERIMENTAL

FYU-981

Drug: FYU-981

Interventions

FYU-981DRUG
Uric acid- underexcretion TypeUric acid- underexcretion Type2Uric acid-overproduction TypeUric acid-overproduction Type (combination)
TopiroxostatDRUG
Also known as: FYX-051
Uric acid-overproduction Type (combination)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Gouty arthritis within a year before start of study treatment
  • Mixed type in the classification of hyperuricemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31734820DERIVED

MeSH Terms

Conditions

Hyperuricemia

Interventions

dotinuradFYX-051

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 19, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

March 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)