Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients

1. Female patient is pregnant, planning to get pregnant, or lactating/breastfeeding.

2. Has a history or presence of CS cardiovascular, renal, pulmonary, hepatic, gallbladder or biliary tract, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, which in the investigator's opinion would not be suitable for the study.

3. Serum creatinine level \> 1.5 mg/dL and/or estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al 2009; National Institute of Diabetes and Digestive and Kidney Diseases, Estimating Glomerular Filtration Rate) at screening.

4. History of stomach or intestinal surgery (except cholecystectomy, appendectomy, and/or hernia repair will be allowed).

5. History of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history within 6 months prior to the screening visit or any alcohol use for at least 48 hours prior to dosing on Day 1.

6. Positive test for human immunodeficiency virus (HIV).

7. Positive test for hepatitis B virus or hepatitis C virus (HCV) consistent with current infection. Confirmatory tests will be allowed at the discretion of the investigator to rule out false positives.

8. Clinically significant abnormal liver function test at screening or check-in (Day -1), defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN) or total bilirubin \> ULN; or a history of CS acute or chronic hepatitis (including infectious, metabolic, autoimmune, genetic, ischemic, or other forms), hepatocirrhosis, or hepatic tumors.

9. Positive screen for alcohol or drugs of abuse (except for patients with a positive drug screen if it is a result of a prescribed medication from their physician) at screening or check-in (Day -1).

10. History of a gout flare that is resolved within 14 days prior to the first dose of study drug on Day 1 (exclusive of chronic synovitis/arthritis). If a gout flare occurs during screening, patients may be rescreened after a period of at least 14 days has passed following the flare.

11. Has a known hypersensitivity to URAT1 inhibitors, XOIs, or related compounds.

12. Receipt of any other investigational product within 30 days prior to the first dose of study drug on Day 1 or planning to take an investigational agent during the study.

13. Use of drugs or nutrients known to significantly modulate cytochrome P450 (CYP)3A activity starting from 14 days prior to the first dose of study drug on Day 1 until EOS (any strong or moderate inhibitors or inducers of CYP3A4, including but not limited to the following: inhibitors such as ketoconazole, miconazole, itraconazole, fluconazole, atazanavir, erythromycin, clarithromycin, ranitidine, cimetidine, verapamil, and diltiazem; and inducers such as rifampicin, rifabutin, glucocorticoids, carbamazepine, phenytoin, phenobarbital, and St. John's wort).

14. Participated in strenuous exercise from 48 hours prior to check-in (Day -1) or during the study through EOS.

15. Has donated or lost a significant volume (\> 500 mL) of blood or plasma within 30 days prior to check-in (Day -1).

16. Malignancy within 5 years prior to the screening visit (excluding basal cell carcinoma).

17. Has problems understanding the protocol requirements, instructions, study-related restrictions, and/or problems understanding the nature, scope, and potential consequences of participating in this clinical study.

18. Is unlikely to comply with the protocol requirements, instructions, and/or study-related restrictions (eg, uncooperative attitude, unavailable for follow up, and/or improbability of completing the clinical study).

Cohorts 1 through 3:

19. Concomitant use of or treatment with any prescription drugs, herbal products, vitamins, minerals, and over-the-counter (OTC) medications that are known to lower sUA levels (eg, allopurinol, febuxistat, probenecid, lesinurad, and peglodicase) within 14 days prior to check-in (Day -1). Exceptions may be made on a case-by-case basis (such as chronic use of low dose aspirin) following discussion and agreement between the investigator and sponsor.

Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients

What this study is about

Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients

What this study is about