Trial Outcomes & Findings for Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia (NCT NCT06056570)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Day 7

Results posted on

2026-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Dotinurad 2mg Period 1: dotinurad 2mg q.d. Period 2: dotinurad 2mg q.d. + allopurinol 300mg q.d. Period 3: allopurinol 300mg q.d.	Dotinurad 4mg Period 1: dotinurad 4mg q.d. Period 2: dotinurad 4mg q.d. + allopurinol 300mg q.d. Period 3: allopurinol 300mg q.d.
Period 1: Dotinurad Monotherapy (7 Days) STARTED	10	10
Period 1: Dotinurad Monotherapy (7 Days) COMPLETED	10	10
Period 1: Dotinurad Monotherapy (7 Days) NOT COMPLETED	0	0
Period 2: Dotinurad+Allopurinol (7 Days) STARTED	10	10
Period 2: Dotinurad+Allopurinol (7 Days) COMPLETED	9	9
Period 2: Dotinurad+Allopurinol (7 Days) NOT COMPLETED	1	1
Period 3: Allopurinol Mono. (7 Days) STARTED	9	9
Period 3: Allopurinol Mono. (7 Days) COMPLETED	9	9
Period 3: Allopurinol Mono. (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dotinurad 2mg n=10 Participants Period 1: dotinurad 2mg q.d. Period 2: dotinurad 2mg q.d. + allopurinol 300mg q.d. Period 3: allopurinol 300mg q.d.	Dotinurad 4mg n=10 Participants Period 1: dotinurad 4mg q.d. Period 2: dotinurad 4mg q.d. + allopurinol 300mg q.d. Period 3: allopurinol 300mg q.d.	Total n=20 Participants Total of all reporting groups
Age, Continuous	58.4 Years STANDARD_DEVIATION 8.60 • n=9 Participants	57.8 Years STANDARD_DEVIATION 4.94 • n=27 Participants	58.1 Years STANDARD_DEVIATION 6.84 • n=267 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	0 Participants n=27 Participants	3 Participants n=267 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	10 Participants n=27 Participants	17 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=9 Participants	7 Participants n=27 Participants	11 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=9 Participants	3 Participants n=27 Participants	9 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) White	9 Participants n=9 Participants	7 Participants n=27 Participants	16 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	2 Participants n=27 Participants	3 Participants n=267 Participants
Baseline BMI	33.21 kg/m^2 STANDARD_DEVIATION 4.885 • n=9 Participants	30.80 kg/m^2 STANDARD_DEVIATION 3.443 • n=27 Participants	32.01 kg/m^2 STANDARD_DEVIATION 4.295 • n=267 Participants

PRIMARY outcome

Timeframe: Day 7

Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=10 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=10 Participants Period 1: dotinurad 4mg q.d.
Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis	161.554 ng/mL Geometric Coefficient of Variation 15.778	291.026 ng/mL Geometric Coefficient of Variation 14.868

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=10 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=10 Participants Period 1: dotinurad 4mg q.d.
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad PK Analysis	1947.193 h*ng/mL Geometric Coefficient of Variation 25.771	3685.293 h*ng/mL Geometric Coefficient of Variation 23.134

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=10 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=10 Participants Period 1: dotinurad 4mg q.d.
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad PK Analysis	1953.016 h*ng/mL Geometric Coefficient of Variation 25.846	3860.090 h*ng/mL Geometric Coefficient of Variation 18.158

PRIMARY outcome

Timeframe: Day 7

Time to maximum plasma concentration (Tmax) of dotinurad, evaluated using median, for pharmacokinetics analysis

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=10 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=10 Participants Period 1: dotinurad 4mg q.d.
Time to Maximum Plasma Concentration (Tmax) - Dotinurad PK Analysis	3.017 h Interval 1.533 to 6.0	4.000 h Interval 2.433 to 6.0

PRIMARY outcome

Timeframe: Day 7

Terminal half-life (T1/2) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=10 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=10 Participants Period 1: dotinurad 4mg q.d.
Terminal Half-life (T1/2) - Dotinurad PK Analysis	10.647 h Geometric Coefficient of Variation 23.025	11.119 h Geometric Coefficient of Variation 19.212

PRIMARY outcome

Timeframe: Day 7 and Day 14

Population: DDI PK Dotinurad analysis population was 7/10 subjects in each arm. * 2 subjects withdrew from the study in period 2 * 1 subject was excluded due to issues with PK data being uninterpretable on Day 14 * 3 subjects were excluded as they did not meet at least 80% compliance with dosing and sufficient PK concentration results to estimate at least one area or Cmax in both Period 1 and Period 2

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.

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=7 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=7 Participants Period 1: dotinurad 4mg q.d.
Peak Plasma Concentration (Cmax) - Dotinurad DDI PK Analysis Dotinurad Monotherapy	172.668 ng/mL Interval 147.243 to 202.484	297.476 ng/mL Interval 249.344 to 354.9
Peak Plasma Concentration (Cmax) - Dotinurad DDI PK Analysis Combination of Dotinurad and Allopurinol	143.813 ng/mL Interval 122.637 to 168.646	261.227 ng/mL Interval 218.96 to 311.654

PRIMARY outcome

Timeframe: Day 7 and Day 14

Population: DDI PK Dotinurad analysis population was 7/10 subjects in each arm. * 2 subjects withdrew from the study in period 2 * 1 subject was excluded due to issues with PK data being uninterpretable on Day 14 * 3 subjects were excluded as they did not meet at least 80% compliance with dosing and sufficient PK concentration results to estimate at least one area or Cmax in both Period 1 and Period 2

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.

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=7 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=7 Participants Period 1: dotinurad 4mg q.d.
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad DDI PK Analysis Dotinurad Monotherapy	2117.772 h*ng/mL Interval 1748.565 to 2564.936	3697.033 h*ng/mL Interval 2929.804 to 4665.177
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad DDI PK Analysis Combination of Dotinurad and Allopurinol	1973.658 h*ng/mL Interval 1629.576 to 2390.393	3517.408 h*ng/mL Interval 2787.455 to 4438.513

PRIMARY outcome

Timeframe: Day 7 and Day 14

Population: DDI PK Dotinurad analysis population was 7/10 subjects in each arm. * 2 subjects withdrew from the study in period 2 * 1 subject was excluded due to issues with PK data being uninterpretable on Day 14 * 3 subjects were excluded as they did not meet at least 80% compliance with dosing and sufficient PK concentration results to estimate at least one area or Cmax in both Period 1 and Period 2

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.

Outcome measures

Outcome measures
Measure	Dotinurad 2mg n=7 Participants Period 1: dotinurad 2mg q.d.	Dotinurad 4mg n=7 Participants Period 1: dotinurad 4mg q.d.
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad DDI PK Analysis Dotinurad Monotherapy	2125.751 h*ng/mL Interval 1755.582 to 2573.971	3947.614 h*ng/mL Interval 3222.824 to 4835.405
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad DDI PK Analysis Combination of Dotinurad and Allopurinol	1977.682 h*ng/mL Interval 1633.298 to 2394.682	3533.854 h*ng/mL Interval 2885.031 to 4328.593

PRIMARY outcome

Timeframe: Day 7 and Day 14

Population: DDI PK Dotinurad analysis population was 7/10 subjects in each arm. * 2 subjects withdrew from the study in period 2 * 1 subject was excluded due to issues with PK data being uninterpretable on Day 14 * 3 subjects were excluded as they did not meet at least 80% compliance with dosing and sufficient PK concentration results to estimate at least one area or Cmax in both Period 1 and Period 2

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.