Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
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
Timeline
- Start
- 2023-10-04
- Primary completion
- 2024-06-27
- Completion
- 2024-07-09
Outcome
Mixed primary results
registry analysis (equivalence test); Dotinurad 2mg; p = .054; Geometric LS Mean Ratio .833 (90% CI .718 to .966); ANOVA NCT06056570 ↗
registry analysis (equivalence test); Dotinurad 2mg; p = .139; Geometric LS Mean Ratio .932 (90% CI 0.860 to 1.010); ANOVA NCT06056570 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allopurinol | Small molecule | 300 mg | — |
| Subject | Dotinurad | Small molecule | 2 mg | — |
| Subject | Dotinurad | Small molecule | 4 mg | — |