NCT06056570

Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Urica Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	dontinurad	dotinurad alone
DRUG	dotinurad + allopurinol	dotinurad + allopurinol 300mg
DRUG	allopurinol	allopurinol 300 mg alone

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-06-27
• Completion: 2024-07-09
• First posted: 2023-09-28
• Last updated: 2025-01-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study