Clinical trial NCT02837198: Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
Official title: Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
timeFrame: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
measure: Pharmacodynamics (Renal clearance of uric acid)
timeFrame: 1-, 4- and 7-day
measure: Pharmacodynamics (Fractional uric acid excretion)
timeFrame: 4- and 7-day
measure: Pharmacodynamics (Maximum delta effective uric acid concentration)
timeFrame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
measure: Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)
timeFrame: 1-, 4- and 7-day
Secondary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (Cmin: Minimum plasma concentration)
timeFrame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 1-, and 7-day
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 1-, and 7-day
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: 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.