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NCT06056570 · ClinicalTrials.gov registry record · Phase 1
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia
A Phase 1 study of Gout and Hyperuricemia, sponsored by Urica Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 4
- Study locations
NCT06056570: Completed Phase 1 study of Gout and Hyperuricemia, sponsored by Urica Therapeutics.
NCT06056570 is a Phase 1 study of Gout and Hyperuricemia that has completed, run by Urica Therapeutics. The registered enrollment target is 20 participants, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06056570, a Phase 1 study of Gout and Hyperuricemia, has completed, sponsored by Urica Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 4
- Study locations
Study 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
Primary Outcome
Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Conditions Studied
Interventions
- DRUG dontinurad
- DRUG dotinurad + allopurinol
- DRUG allopurinol
Study Locations (4)
Florida
- Clinical Research of West Florida - Clearwater
- Panax Clinical Research - Miami Lakes
Texas
- Southwest Rheumatology Research - Mesquite
- Endeavor Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 1 |
What the finished NCT06056570 record still lists
NCT06056570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Gout appearing as the primary indexed condition, and to 3 interventions - of which dontinurad is the first listed.
NCT06056570 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT06056570 about?
NCT06056570 is a clinical study titled "Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia". 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 al...
What is the current status of trial NCT06056570?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-10-04. Estimated completion is 2024-07-09.
What conditions does trial NCT06056570 study?
This clinical trial studies the following conditions: Gout, Hyperuricemia.
What interventions are being tested in trial NCT06056570?
The interventions under investigation include: dontinurad (DRUG), dotinurad + allopurinol (DRUG), allopurinol (DRUG).
Who is sponsoring clinical trial NCT06056570?
This trial is sponsored by Urica Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06056570 being conducted?
This trial has 4 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06056570's enrollment target sits among peer trials
20 30th of 34 higher than 4 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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