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

Inclusion Criteria:

• 1. In the opinion of the investigator, the patient is capable of understanding andcomplying with protocol requirements.

2. Patients with a diagnosis of gout based on American College of Rheumatologycriteria (1997). Patients must fulfill at least 3 of the following, with one ofthose 3 being (i) hyperuricemia.

3. More than one attack of acute arthritis

4. Maximum inflammation developed within 1 day

5. Monoarthritis attack

6. Redness observed over joints

7. First metatarsophalangeal joint painful or swollen

8. Unilateral first metatarsophalangeal joint attack

9. Unilateral tarsal joint attack

10. Tophus (proven or suspected)

11. Hyperuricemia.

12. Asymmetric swelling within a joint on x-ray

13. Subcortical cysts without erosions on x-ray

14. Monosodium urate monohydrate microcrystals on joint fluid during attack

15. Joint fluid culture negative for organisms during attack 3. The patient signsand dates a written, informed consent form and any required privacyauthorization prior to the initiation of any study procedures includingrequesting that a patient fast for any laboratory evaluations.

16. Negative COVID-19 test by either PCR or rapid antigen test at screening andcheck-in prior to first period, and agrees to be compliant with all COVID-19measures mandated by the CRU prior to screening/entry into the trial.

17. 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 historyof twelve consecutive months of amenorrhea, or FSH levels) or females ofchildbearing potential must be on a reliable method of birth control and alsohave a negative urine human chorionic gonadotropin (hCG) pregnancy test resultson the Study Day -1.

18. Screening serum uric acid level of ≥7 mg/dl. a. If a patient is not on uric acid-lowering therapies (ULT) prior to screening, therequired fasting sUA level is at least one ≥7 mg/dl during Screening b. If a patientis on ULT prior to screening, the required fasting sUA level is at least one =>7mg/dl between Day -7 and Day -1 7. Screening liver enzymes (LFTs) <1.5x ULN. Totalbilirubin <1x ULN. For patients with documented Gilbert Syndrome, total bilirubin ≤3x ULN with direct bilirubin <1x ULN.

19. Screening renal function eGFR ≥ 60 mL/min/1.73m2. 9. Pre-dose hemoglobin shouldbe within the normal range. 10. Body mass index (BMI) ≥ 18.5 and ≤ 40.0 (kg/m2) anda body weight of no less than 50 kg.

20. Medically healthy with no clinically significant screening results including butnot limited to:

21. Laboratory profiles other than sUA

22. Urinalysis

23. Vital signs

24. Electrocardiograms (ECGs)

25. Physical examination 12. No use of tobacco or nicotine containing products (including smoking cessation products), for a minimum of 3 months prior todosing.

Exclusion Criteria:

• 1. The subject has current or historical evidence of any clinically significantdisease or condition that might complicate the subject's participation, or, in theopinion of the Investigator, may place the subject at an unacceptable risk as aparticipant in this trial, may interfere with the interpretation of safety and/ortolerability 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 heartfailure, myocardial infarction, stroke, or deep venous thrombosis within 1 yearprior to Day 1.

3. QT interval corrected for heart rate according to Fridericia's formula >470 msecin females and >450 msec in males during Screening, confirmed by a repeatassessment.

4. History of or presence of kidney stones. 5. History of or presence of malignancyin the last 5 years other than treated cutaneous basal or squamous cell carcinoma.

5. Urological disorder not well controlled. 7. Peptic ulcer disease requiring activetreatment. 8. Cannot safely discontinue uric acid-lowering medication 14 days priorto study start to 9 days after the last dose of study medication was administered.

6. Surgery within the past 90 days prior to dosing as determined by the PrincipalInvestigator to be clinically relevant.

7. Use of agents that could confound serum uric acid analysis (eg, long-term use ofsalicylates >100 mg or use of losartan).

8. Patients with an acute gout flare during the screening period that had notresolved 1 week prior to the first dose of study.

9. Hypersensitivity or intolerance to allopurinol, dotinurad or colchicine. 13.Positive for HLA-B*58:01 allele 14. History or presence of alcoholism or chronicdrug abuse within the past 2 years.

10. Psychiatric disorder or social situation that prevents compliance with theprotocol.

11. Female patients who are pregnant or lactating. 17. Positive results for theurine drug /alcohol breath test/cotinine at check-in.

12. Positive results at screening for Human Immunodeficiency Virus (HIV), HepatitisB Surface Antigen (HBsAg), Hepatitis C antibodies (HCV).

13. Patient's semi-recumbent blood pressure is less than 90/40 mmHg or greater than 155/90 mmHg during Screening and Day -1.

14. Stable dose of medications for long-term conditions such as diabetes, highcholesterol, hypertension, asthma, etc. are allowed (provided that the patient hasbeen on a stable dose for at least 30 days prior to Screening and is not expected torequire dose adjustment during the study through 7 days post study).

15. Patient reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gpinhibitor within 1 month prior to study drug dosing, due to potential interactionswith colchicine.

16. Patient has taken azathioprine, Imuran, or other medications that may interactwith allopurinol within 1 month prior to study drug dosing 23. Participation inanother 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 trialprior to screening for this trial. Previous participation in a dotinurad trial isalso exclusionary.