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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02837198

Enrollment

Registered

2016-07-19

Start date

2016-07-31

Completion date

2018-03-31

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia

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.

Interventions

DRUGFYU-981

DRUGTopiroxostat

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)	1-, 4- and 7-day
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

Secondary

Measure	Time frame
Pharmacokinetics (kel: Elimination rate constant)	1-, and 7-day
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)	1-, and 7-day
Pharmacokinetics (Cmax: Maximum plasma concentration)	1-, and 7-day
Pharmacokinetics (MRT: Mean residence time)	1-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026