Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06056570
The ClinicalTrials.gov registry entry for NCT06056570 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower). The listed sponsor is Urica Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.
-
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
ACTIVE NOT RECRUITING · Phase 1
-
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
COMPLETED · Phase 1
-
Mild, Moderate and Severe Renal Impairment Study
COMPLETED · Phase 1
-
The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
COMPLETED · Phase 1
-
NSAID Drug Interaction Study
COMPLETED · Phase 1
-
Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.