GoutPhase 1/2NCT06056570
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
A Phase 1/2 study testing dotinurad, dotinurad + allopurinol and allopurinol in people with Gout and Hyperuricemia, run by Urica Therapeutics Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- dotinurad, dotinurad + allopurinol and allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Oct 2023to 9 Jul 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- More than one attack of acute arthritis
- Maximum inflammation developed within 1 day
- Monoarthritis attack
- Redness observed over joints
Show all 26Show fewer
- First metatarsophalangeal joint painful or swollen
- Unilateral first metatarsophalangeal joint attack
- Unilateral tarsal joint attack
- Tophus (proven or suspected)
- Hyperuricemia.
- Asymmetric swelling within a joint on x-ray
- Subcortical cysts without erosions on x-ray
- Monosodium urate monohydrate microcrystals on joint fluid during attack
- Joint fluid culture negative for organisms during attack 3. The patient signs and dates a written, informed consent 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 childbearing potential must be on a reliable method of birth control 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.
- 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 ULN. Total bilirubin <1x ULN. For patients with documented Gilbert Syndrome, total bilirubin ≤3 x ULN with direct bilirubin <1x ULN.
- 8. Screening renal function eGFR ≥ 60 mL/min/1.73m2. 9. Pre-dose hemoglobin should be within the normal range. 10. Body mass index (BMI) ≥ 18.5 and ≤ 40.0 (kg/m2) and a body weight of no less than 50 kg.
- 11. Medically healthy with no clinically significant screening results including but not limited to:
- Laboratory profiles other than sUA
- Urinalysis
- Vital signs
- Electrocardiograms (ECGs)
- Physical examination 12. No use of tobacco or nicotine containing products (including smoking cessation products), for a minimum of 3 months prior to dosing.
Who cannot join
- 1. The subject has current or historical evidence of any clinically significant 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, New York Heart Association Class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within 1 year prior to Day 1.
- 3. QT interval 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 malignancy 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.
Show all 16Show fewer
- 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. Hypersensitivity or intolerance to allopurinol, dotinurad or colchicine. 13. Positive for HLA-B58:01 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 Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), Hepatitis C 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 CYP3A4 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Research of West Florida
Clearwater, Florida, 33765
Southwest Rheumatology Research
Mesquite, Texas, 75150
Panax Clinical Research
Miami Lakes, Florida, 33014
Endeavor Clinical Trials
San Antonio, Texas, 78240
About this study
Official title: A Phase 1B Open Label Evaluation of the PK and PD of Dotinurad and Drug-Drug Interaction of Dotinurad and Allopurinol in U.S. Patients With Gout and 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 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
- Gout, Hyperuricemia
- Being tested
- dotinurad, dotinurad + allopurinol, allopurinol
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dotinuradDrug
dotinurad alone
dotinurad + allopurinolDrug
dotinurad + allopurinol 300mg
allopurinolDrug
allopurinol 300 mg alone
| Study group | Role | What they receive |
|---|---|---|
| dotinurad 2mg | Experimental | dotinurad 2mg q.d. Receives: Drug: dotinurad; Drug: dotinurad + allopurinol; Drug: allopurinol |
| dotinurad 4mg | Experimental | dotinurad 4mg q.d. Receives: Drug: dotinurad; Drug: dotinurad + allopurinol; Drug: allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis
Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Measured: 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
Measured: 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
Measured: 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
Measured: Day 7
Terminal Half-life (T1/2) - Dotinurad PK Analysis
Terminal half-life (T1/2) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Oct 2023
- Primary completion27 Jun 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urica Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056570
- Sponsor's protocol ID
- UR1-DOT-103
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2023
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Open Label Evaluation of the PK and PD of Dotinurad and Drug-Drug Interaction of Dotinurad and Allopurinol in U.S. Patients With Gout and Hyperuricemia
- ClinicalTrials.gov ID
- NCT06056570
- Acronym / sponsor ID
- UR1-DOT-103
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Urica Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dotinurad 2mg | Experimental | Drug: dotinurad, Drug: dotinurad + allopurinol, Drug: allopurinoldotinurad 2mg q.d. |
| dotinurad 4mg | Experimental | Drug: dotinurad, Drug: dotinurad + allopurinol, Drug: allopurinoldotinurad 4mg q.d. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
- 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 childbearing potential must be on a reliable method of birth control 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.
Key exclusion criteria (16 listed)
- 1. The subject has current or historical evidence of any clinically significant 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, New York Heart Association Class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within 1 year prior to Day 1.
- 3. QT interval 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 malignancy 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dotinuraddotinurad alone | Drug | dotinurad 2mg, dotinurad 4mg |
| dotinurad + allopurinoldotinurad + allopurinol 300mg | Drug | dotinurad 2mg, dotinurad 4mg |
| allopurinolallopurinol 300 mg alone | Drug | dotinurad 2mg, dotinurad 4mg |
Primary outcome
Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis
Time frame: Day 7
Peak plasma concentrations (Cmax) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad PK Analysis
Time frame: 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
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad PK Analysis
Time frame: 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
Time to Maximum Plasma Concentration (Tmax) - Dotinurad PK Analysis
Time frame: Day 7
Time to maximum plasma concentration (Tmax) of dotinurad, evaluated using median, for pharmacokinetics analysis
Terminal Half-life (T1/2) - Dotinurad PK Analysis
Time frame: Day 7
Terminal half-life (T1/2) of dotinurad, evaluated using geometric mean, for pharmacokinetics analysis
Peak Plasma Concentration (Cmax) - Dotinurad DDI PK Analysis
Time frame: 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.
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad DDI PK Analysis
Time frame: 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.
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad DDI PK Analysis
Time frame: 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.
Terminal Half-life (T1/2) - Dotinurad DDI PK Analysis
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gout
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dotinurad, dotinurad + allopurinol and allopurinol in people with Gout and Hyperuricemia, run by Urica Therapeutics Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis (time frame: Day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.