At a glance
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A Phase 1B Open Label Evaluation of the PK and PD of Dotinurad and Drug-Drug Interaction of Dotinurad and Allopurinol in U.S. Patients With Gout and Hyperuricemia
In Brief
A Phase 1 clinical trial evaluating dotinurad, dotinurad + allopurinol, and 1 other intervention for Gout and Hyperuricemia. Completed, enrolled 20 participants across 4 sites.
Signals
Detailed Summary
A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to evaluate the effect of dotinurad, as monotherapy and in combination with allopurinol, versus allopurinol monotherapy, on the PK of each, and to assess the additive PD effects on serum uric acid and urinary urate excretion in U.S. patients with gout and hyperuricemia
Study Details
Timeline
Arms & Interventions
dotinurad 2mg q.d.
dotinurad 4mg q.d.
Interventions
dotinurad alone
dotinurad + allopurinol 300mg
allopurinol 300 mg alone