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

Sponsor

Fuji Yakuhin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02837198

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: FYU-981 Drug: Topiroxostat	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Pharmacokinetics (kel: Elimination rate constant) [1-, and 7-day]
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) [1-, and 7-day]
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) [1-, and 7-day]
Pharmacokinetics (MRT: Mean residence time) [1-, and 7-day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tokyo		Japan

Sponsors and Collaborators

Fuji Yakuhin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fuji Yakuhin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02837198

Other Study ID Numbers:

FYU-981-008

First Posted:

Jul 19, 2016

Last Update Posted:

Aug 21, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hyperuricemia

Dotinurad

FYX-051

Study Results

No Results Posted as of Aug 21, 2018