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FYU-981 (Dotinurad) Repeated Dose Study in Hyperuricemia
NCT02837198Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2016
- Primary completion
- Aug 2017
- Countries
- 1
- Sponsor
- Fuji Yakuhin
- Modality
- Small Molecules
- Drugs
- dotinurad
- Conditions
- hyperuricemia
01
Overview
Phase 2, open-label trial of dotinurad in hyperuricemia (4 arms), sponsored by Fuji Yakuhin. Primary endpoints: Amount of uric acid excreted in urine at 9 days, Renal clearance of uric acid at 7 days and 3 more. Started Jul 2016; status: completed.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Overproduction Type (Mono)
FYU-981 monotherapy in uric acid overproduction type.
Underexcretion Type (Mono)
FYU-981 monotherapy in uric acid underexcretion type.
Overproduction Type (Combo)
FYU-981 + Topiroxostat in uric acid overproduction type.
Underexcretion Type 2 (Mono)
FYU-981 monotherapy in uric acid underexcretion type (second cohort).
03
Who it enrols
Japanese adult male patients with hyperuricemia (overproduction or underexcretion type) and serum urate >= 7.0 mg/dL, excluding those with recent gouty arthritis or mixed type hyperuricemia.
04
Endpoints
Primary
Amount of uric acid excreted in urine
Renal clearance of uric acid
Fractional uric acid excretion
Maximum delta effective uric acid concentration
Delta area under the serum uric acid concentration-time curve
Secondary
Maximum plasma concentration
Minimum plasma concentration
Time to reach the peak plasma concentration
Elimination half-life of plasma concentration
Area under the plasma concentration-time curve
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