A Phase 1/2 interventional study of dotinurad and dotinurad + allopurinol in Gout and Hyperuricemia, sponsored by Urica Therapeutics Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Urica Therapeutics Inc. · Phase 1/2, Interventional, and Treatment
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Among 10 studies testing dotinurad in Gout — 4 open to participants now, 4 under way, 1 of them phase 3. dotinurad · Gout.
Among the 10 studies testing dotinurad in Gout, this one is the 10th largest by enrollment, is the only one that started in 2023, is the only one in phase 1/2, and was the 6th registered.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
Browse Gout studies →4 of the 10 studies testing dotinurad in Gout are open now, in 4 countries. Recruiting first, the newest first:
Crystalys Therapeutics · Sites in United States
Ages 18–75
Crystalys Therapeutics · Sites in United States, Poland, Spain
Ages 18–75
Saga University · Sites in Japan
Ages 20+
First Affiliated Hospital of Wenzhou Medical University
Ages 18–70
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 5 · Phase 4 2
First in 2016; this study’s year is marked. 1 started in 2023.
This study's enrollment of 20 is below the median of 83 across 286 interventional studies indexed under Gout.
Median enrollment 202 across the 10 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 10 have an industry lead sponsor. The 7 most frequent:
This is the only study on the registry with Urica Therapeutics Inc. as lead sponsor.
Urica Therapeutics Inc. has 1 study filed under Gout — fewer than ten, so there is no comparison to draw.
4 of the studies testing dotinurad in Gout that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07089875Phase 3Crystalys TherapeuticsA Study of Dotinurad Versus Allopurinol in Participants With Gout | 2027-11-29 |
| NCT07535034Crystalys TherapeuticsA Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants | 2027-07 |
| NCT07661030First Affiliated Hospital of Wenzhou Medical UniversityThe Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time | 2027-07-30 |
| NCT06834230Saga UniversityEffect of Dotinurad in Hyperuricemia With Hypertension | 2027-07-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 10 studies testing dotinurad in Gout, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
2. Patients with a diagnosis of gout based on American College of Rheumatology criteria (1997). Patients must fulfill at least 3 of the following, with one of those 3 being (i) hyperuricemia.
Joint fluid culture negative for organisms during attack 3. The patient signs and dates a written, form and any required privacy authorization prior to the initiation of any study procedures including requesting that a patient fast for any laboratory evaluations.
4. Negative COVID-19 test by either PCR or rapid antigen test at screening and check-in prior to first period, and agrees to be compliant with all COVID-19 measures mandated by the CRU prior to screening/entry into the trial.
5. Male or female between 18 and 75 years of age (inclusive). To be eligible, females can be either of NCBP (confirmed by surgical history, medical history of twelve consecutive months of amenorrhea, or FSH levels) or females of must be on a reliable method of and also have a negative urine human chorionic gonadotropin (hCG) pregnancy test results on the Study Day -1.
6. Screening serum uric acid level of ≥7 mg/dl.
a. If a patient is not on uric acid-lowering therapies (ULT) prior to screening, the required fasting sUA level is at least one ≥7 mg/dl during Screening b. If a patient is on ULT prior to screening, the required fasting sUA level is at least one =>7 mg/dl between Day -7 and Day -1 7. Screening liver enzymes (LFTs) \<1.5x . Total \<1x ULN. For patients with documented Gilbert Syndrome, total bilirubin ≤3 x ULN with direct bilirubin \<1x ULN.
8. Screening renal function ≥ 60 mL/min/1.73m2. 9. Pre-dose should be within the normal range. 10. (BMI) ≥ 18.5 and ≤ 40.0 (kg/m2) and a body weight of no less than 50 kg.
11. Medically healthy with no screening results including but not limited to:
Exclusion Criteria:
1. The subject has current or historical evidence of any disease or condition that might complicate the subject's participation, or, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in this trial, may interfere with the interpretation of safety and/or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of the study drug.
2. Patients with unstable angina, Class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within 1 year prior to Day 1.
3. corrected for heart rate according to Fridericia's formula >470 msec in females and >450 msec in males during Screening, confirmed by a repeat assessment.
4. History of or presence of kidney stones. 5. History of or presence of in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
6. Urological disorder not well controlled. 7. Peptic ulcer disease requiring active treatment. 8. Cannot safely discontinue uric acid-lowering medication 14 days prior to study start to 9 days after the last dose of study medication was administered.
9. Surgery within the past 90 days prior to dosing as determined by the Principal Investigator to be clinically relevant.
10. Use of agents that could confound serum uric acid analysis (eg, long-term use of salicylates >100 mg or use of losartan).
11. Patients with an acute gout flare during the screening period that had not resolved 1 week prior to the first dose of study.
12. or intolerance to allopurinol, dotinurad or colchicine. 13. Positive for HLA-B*58:01 allele 14. History or presence of alcoholism or chronic drug abuse within the past 2 years.
15. Psychiatric disorder or social situation that prevents compliance with the protocol.
16. Female patients who are pregnant or lactating. 17. Positive results for the urine drug /alcohol breath test/cotinine at check-in.
18. Positive results at screening for (HIV), Surface Antigen (HBsAg), antibodies (HCV).
19. Patient's semi-recumbent blood pressure is less than 90/40 mmHg or greater than 155/90 mmHg during Screening and Day -1.
20. Stable dose of medications for long-term conditions such as diabetes, high cholesterol, hypertension, asthma, etc. are allowed (provided that the patient has been on a stable dose for at least 30 days prior to Screening and is not expected to require dose adjustment during the study through 7 days post study).
21. Patient reports receiving a strong or moderate inhibitor of or a P-gp inhibitor within 1 month prior to study drug dosing, due to potential interactions with colchicine.
22. Patient has taken azathioprine, Imuran, or other medications that may interact with allopurinol within 1 month prior to study drug dosing 23. Participation in another clinical trial within 30 days of last IP administration or 5 half-lives (whichever is longer) of administration of any study drug evaluated in that trial prior to screening for this trial. Previous participation in a dotinurad trial is also exclusionary.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
dotinurad 2mg q.d.
Drug: dotinurad · Drug: dotinurad + allopurinol · Drug: allopurinol
dotinurad 4mg q.d.
Drug: dotinurad · Drug: dotinurad + allopurinol · Drug: allopurinol
dotinurad alone
Drug pages: Dotinurad · Allopurinol
dotinurad + allopurinol 300mg
allopurinol 300 mg alone
Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis
Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Time frame: Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad PK Analysis
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
Time frame: Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad PK Analysis
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
Time frame: Day 7
Time to Maximum Plasma Concentration (Tmax) - Dotinurad PK Analysis
Time to maximum plasma concentration (Tmax) of dotinurad, evaluated using median, for pharmacokinetics analysis
Time frame: Day 7
Terminal Half-life (T1/2) - Dotinurad PK Analysis
Terminal half-life (T1/2) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Time frame: Day 7
Peak Plasma Concentration (Cmax) - Dotinurad DDI PK Analysis
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.
Time frame: Day 7 and Day 14
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad DDI PK Analysis
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.
Time frame: Day 7 and Day 14
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad DDI PK Analysis
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.
Time frame: Day 7 and Day 14
Terminal Half-life (T1/2) - Dotinurad DDI PK Analysis
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.
Time frame: Day 7 and Day 14
| Milestone | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 9 |
| Not completed | 1 | 1 |
| Milestone | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Started | 9 | 9 |
| Completed | 9 | 9 |
| Not completed | 0 | 0 |
Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
| ng/mL | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis | 161.554 ± 15.778 | 291.026 ± 14.868 |
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
| h*ng/mL | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad PK Analysis | 1947.193 ± 25.771 | 3685.293 ± 23.134 |
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
| h*ng/mL | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad PK Analysis | 1953.016 ± 25.846 | 3860.090 ± 18.158 |
Time to maximum plasma concentration (Tmax) of dotinurad, evaluated using median, for pharmacokinetics analysis
| h | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Dotinurad PK Analysis | 3.017 (1.533 to 6.00) | 4.000 (2.433 to 6.000) |
Terminal half-life (T1/2) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
| h | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Terminal Half-life (T1/2) - Dotinurad PK Analysis | 10.647 ± 23.025 | 11.119 ± 19.212 |
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.
| ng/mL | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Dotinurad Monotherapy | 172.668 (147.243 to 202.484) | 297.476 (249.344 to 354.900) |
| Combination of Dotinurad and Allopurinol | 143.813 (122.637 to 168.646) | 261.227 (218.960 to 311.654) |
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.
| h*ng/mL | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Dotinurad Monotherapy | 2117.772 (1748.565 to 2564.936) | 3697.033 (2929.804 to 4665.177) |
| Combination of Dotinurad and Allopurinol | 1973.658 (1629.576 to 2390.393) | 3517.408 (2787.455 to 4438.513) |
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.
| h*ng/mL | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Dotinurad Monotherapy | 2125.751 (1755.582 to 2573.971) | 3947.614 (3222.824 to 4835.405) |
| Combination of Dotinurad and Allopurinol | 1977.682 (1633.298 to 2394.682) | 3533.854 (2885.031 to 4328.593) |
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.
| h | Dotinurad 2mg | Dotinurad 4mg |
|---|---|---|
| Dotinurad Monotherapy | 11.530 (9.493 to 13.567) | 11.563 (9.385 to 13.741) |
| Combination of Dotinurad and Allopurinol | 11.328 (9.291 to 13.365) | 11.192 (9.014 to 13.370) |
Collected over Total treatment duration of 21 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dotinurad 2mg Monotherapy | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Dotinurad 4mg Monotherapy | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Dotinurad 2mg + Allopurinol 300mg | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Dotinurad 4mg + Allopurinol 300mg | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| Allopurinol 300mg Monotherapy (From Dotinurad 2mg Arm) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Allopurinol 300mg Monotherapy (From Dotinurad 4mg Arm) | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Event | Dotinurad 2mg Monotherapy | Dotinurad 4mg Monotherapy | Dotinurad 2mg + Allopurinol 300mg | Dotinurad 4mg + Allopurinol 300mg | Allopurinol 300mg Monotherapy (From Dotinurad 2mg Arm) | Allopurinol 300mg Monotherapy (From Dotinurad 4mg Arm) |
|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 0/10 | 0/10 | 0/10 | 0/10 | 0/9 | 1/9 |
| Abdominal painGastrointestinal disorders | 1/10 | 0/10 | 0/10 | 0/10 | 0/9 | 0/9 |
| ConstiptationGastrointestinal disorders | 0/10 | 0/10 | 0/10 | 1/10 | 0/9 | 0/9 |
| DiarrhoeaGastrointestinal disorders | 1/10 | 0/10 | 0/10 | 0/10 | 0/9 | 0/9 |
| GoutMetabolism and nutrition disorders | 0/10 | 1/10 | 0/10 | 1/10 | 0/9 | 0/9 |
| HypoesthesiaNervous system disorders | 0/10 | 1/10 | 0/10 | 0/10 | 0/9 | 0/9 |
| Influenza like illnessGeneral disorders | 0/10 | 0/10 | 1/10 | 0/10 | 0/9 | 0/9 |
| Upper respiratory tract infectionInfections and infestations | 0/10 | 0/10 | 1/10 | 0/10 | 0/9 | 0/9 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/10 | 0/10 | 0/10 | 0/10 | 0/9 | 0/9 |
| ThrombophlebitisVascular disorders | 1/10 | 0/10 | 0/10 | 0/10 | 0/9 | 0/9 |
| Age, Continuous(Years) | Dotinurad 2mg | Dotinurad 4mg | Total |
|---|---|---|---|
| Mean | 58.4 ± 8.60 | 57.8 ± 4.94 | 58.1 ± 6.84 |
| Sex: Female, Male(Participants) | Dotinurad 2mg | Dotinurad 4mg | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 7 | 10 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Dotinurad 2mg | Dotinurad 4mg | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 11 |
| Not Hispanic or Latino | 6 | 3 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dotinurad 2mg | Dotinurad 4mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 7 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Baseline BMI(kg/m^2) | Dotinurad 2mg | Dotinurad 4mg | Total |
|---|---|---|---|
| Mean | 33.21 ± 4.885 | 30.80 ± 3.443 | 32.01 ± 4.295 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2023 to primary completion in Jun 2024, 8 months.
Results were first posted in Jun 2026, 1 year 11 months after primary completion.
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Studies of the drugs tested here: Dotinurad · Allopurinol