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

Exclusion Criteria

• •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.
• •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-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 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.