Trial · NCT06056570
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
NCT06056570, Phase 1, Phase 2, Completed, Urica Therapeutics Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia. Trials, record NCT06056570. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06056570
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
- NCT number
- NCT06056570
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Urica Therapeutics Inc.
- Conditions
- Gout, Hyperuricemia
- Interventions
- dotinurad, dotinurad + allopurinol, allopurinol
- First posted
- 2023-09-28
- Last updated
- 2026-06-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis | Day 7 | Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis |
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad PK Analysis | Day 7 | Area under the plasma concentration versus time curve (AUC 0-last)\* of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis \*area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated using linear-up log-down trapezoidal summation |
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad PK Analysis | Day 7 | Area under the plasma concentration versus time curve (AUC 0-τ)\* of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis \*inter-dose interval area under the concentration-time curve from time 0 to the time of next dose, calculated using linear-up log-down trapezoidal summation |
| Primary | Time to Maximum Plasma Concentration (Tmax) - Dotinurad PK Analysis | Day 7 | Time to maximum plasma concentration (Tmax) of dotinurad, evaluated using median, for pharmacokinetics analysis |
| Primary | Terminal Half-life (T1/2) - Dotinurad PK Analysis | Day 7 | Terminal half-life (T1/2) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis |
| Primary | Peak Plasma Concentration (Cmax) - Dotinurad DDI PK Analysis | Day 7 and Day 14 | Peak plasma concentration (Cmax) of dotinurad, evaluated using Geometric Least Squares Mean\*, for DDI analysis \* Geometric LS Mean, Geometric LS Mean Ratio, CI, and p-value were calculated using ANOVA model on log-transformed parameters (Areas, Cmax, and Ae0-24) considering treatment, dose group and treatment-by-dose group as fixed effects and subject nested, within dose group as a random effect and was performed using SAS proc Mixed. If the treatment-by-dose group interaction was not significant at the 10% level, then it was dropped from the model. |
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad DDI PK Analysis | Day 7 and Day 14 | Area under the plasma concentration versus time curve (AUC 0-last)\* of dotinurad, evaluated using Geometric Least Squares Mean\*\*, for DDI analysis \*area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated using linear-up log-down trapezoidal summation \*\* Geometric LS Mean, Geometric LS Mean Ratio, CI, and p-value were calculated using ANOVA model on log-transformed parameters (Areas, Cmax, and Ae0-24) considering treatment, dose group and treatment-by-dose group as fixed effects and subject nested, within dose group as a random effect and was performed using SAS proc Mixed. If the treatment-by-dose group interaction was not significant at the 10% level, then it was dropped from the model. |
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad DDI PK Analysis | Day 7 and Day 14 | Area under the plasma concentration versus time curve (AUC 0-τ)\* of dotinurad, evaluated using Geometric Least Squares Mean\*\*, for DDI analysis \*inter-dose interval area under the concentration-time curve from time 0 to the time of next dose, calculated using linear-up log-down trapezoidal summation \*\* Geometric LS Mean, Geometric LS Mean Ratio, CI, and p-value were calculated using ANOVA model on log-transformed parameters (Areas, Cmax, and Ae0-24) considering treatment, dose group and treatment-by-dose group as fixed effects and subject nested, within dose group as a random effect and was performed using SAS proc Mixed. If the treatment-by-dose group interaction was not significant at the 10% level, then it was dropped from the model. |
| Primary | Terminal Half-life (T1/2) - Dotinurad DDI PK Analysis | Day 7 and Day 14 | Terminal half-life (T1/2) of dotinurad, evaluated using Least Squares Mean\*, for DDI analysis \*LS Mean, LS Mean Difference, CI, and p-value were calculated using ANOVA model on parameters (t1/2, CL/F, Vz/F, fe0-24, and CLR) considering treatment, dose group and treatment-by-dose group as fixed effects and subject nested within dose group as a random effect and was performed using SAS proc Mixed. If the treatment-by-dose group interaction was not significant at the 10% level, then it was dropped from the model. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06056570
GET https://conductscience.org/api/trials/v1/NCT06056570/registered