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

Part of paid clinical trials in Clearwater, Florida.

Sponsor
Urica Therapeutics Inc.
Study ID
NCT06056570
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 4, 2023
Status verified
Jun 2026
Primary completion
Jun 27, 2024
Completion
Jul 9, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: dotinurad 2mg
    dotinurad 2mg q.d.
  • Experimental: dotinurad 4mg
    dotinurad 4mg q.d.

Primary Outcome Measure

Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis [ Time Frame: Day 7 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Research of West FloridaClearwaterFlorida33765-
Panax Clinical ResearchMiami LakesFlorida33014-
Southwest Rheumatology ResearchMesquiteTexas75150-
Endeavor Clinical TrialsSan AntonioTexas78240-

Find similar trials in Clearwater, FL

By research site
Clinical Research of West Florida· Clearwater, FLPanax Clinical Research· Miami Lakes, FLSouthwest Rheumatology Research· Mesquite, TXEndeavor Clinical Trials· San Antonio, TX

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