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

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Urica Therapeutics Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Screening serum uric acid level of ≥7 mg/dl.

Body mass index (BMI) ≥ 18.5 and ≤ 40.0 (kg/m2) and a body weight of no less than 50 kg.

In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.

Exclusion Criteria

Cannot safely discontinue uric acid-lowering medication 14 days prior to study start to 9 days after the last dose of study medication was administered.

Surgery within the past 90 days prior to dosing as determined by the Principal Investigator to be clinically relevant.

Use of agents that could confound serum uric acid analysis (eg, long-term use of salicylates >100 mg or use of losartan).

Treatment Details

Interventions

• Allopurinol (Xanthine Oxidase Inhibitor)
• Dotinurad (Uricosuric Agent)

Participant Groups

Group I: dotinurad 4mg Experimental Treatment 3 Interventions

dotinurad 4mg q.d.

Group II: dotinurad 2mg Experimental Treatment 3 Interventions

dotinurad 2mg q.d.

Allopurinol is already approved in Canada, Japan for the following indications:

Approved in Canada as Allopurinol for:

• Gout
• Kidney stones
• High uric acid levels after chemotherapy

Approved in Japan as Allopurinol for:

• Gout
• Kidney stones
• High uric acid levels after chemotherapy

Who Is Running the Clinical Trial?

Urica Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

20+