Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
NCT ID: NCT03857165
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2018-09-24
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Low dose SAP-001
SAP-001 (Experimental drug) low dose versus placebo
SAP-001
SAP-001 or placebo treatment in a 3:1 randomization ratio.
Mid dose SAP-001
SAP-001 (Experimental drug) mid dose versus placebo
SAP-001
SAP-001 or placebo treatment in a 3:1 randomization ratio.
High dose SAP-001
SAP-001 (Experimental drug) high dose versus placebo
SAP-001
SAP-001 or placebo treatment in a 3:1 randomization ratio.
Interventions
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SAP-001
SAP-001 or placebo treatment in a 3:1 randomization ratio.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) between 19 and 42 kg/m\^2 at screening, inclusive.
3. Serum uric acid (sUA) levels ≥7.5 mg/dL at screening.
4. Patients must meet all the American College of Rheumatology scoring criteria for the classification of primary gout (Neogi et al., 2015).
5. Patients who are not taking any UA-lowering medications 1 month prior to the dose of study drug.
6. Is a nonsmoker or light smoker (smokes fewer than 10 cigarettes per day).
7. Female patients cannot be pregnant or lactating/breast-feeding and will either be postmenopausal (female patients who state they are postmenopausal should have had cessation of menses for\>1 year and have serum follicle stimulating hormone \[FSH\] levels \>40 mIU/mL and serum estradiol \< 20 pg/mL or a negative estrogen test), surgically sterile (including bilateral tubal ligation, salpingectomy \[with or without oophorectomy\], surgical hysterectomy, or bilateral oophorectomy \[with or without hysterectomy\]) for at least 3 months prior to Screening, or will agree to use, from the time of Check-in (Day -1) until 90 days following the last dose of study drug, the following forms of contraception: double-barrier method, hormonal contraceptives, barrier with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, oral, implantable, or injectable contraceptives, or a sterile sexual partner. All female patients will have a negative urine or serum pregnancy test result prior to enrollment in the study.
8. Male patients will either be surgically sterile or agree to use, from the time of Check-in (Day -1) until 90 days following the last dose of study drug, the following forms of contraception: male condom with spermicide and a female partner who is sterile or agrees to use hormonal contraceptives, female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, oral, implantable, or injectable contraceptives. Male patients will refrain from sperm donation from the time of Check-in (Day -1) until 90 days following the last dose of study drug.
9. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
Exclusion Criteria
2. Serum creatinine level \> 1.5 mg/dL and/or estimated glomerular filtration (eGFR) by the Modification of Diet in Renal Disease (MDRD) rate ≤60 mL/min/1.73 m2 at screening. The MDRD formula is: GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)
3. History of stomach or intestinal surgery (except that cholecystectomy, appendectomy, and/or hernia repair will be allowed).
4. 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.
5. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C (HCV) antibody.
6. Clinically significant abnormal liver function test at screening or Check-in (Day -1), defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>1.5 times upper limit of normal (ULN) or total bilirubin \>ULN; or a history of clinically significant acute or chronic hepatitis (including infectious, metabolic, autoimmune, genetic, ischemic, or other forms), hepatocirrhosis, or hepatic tumors.
7. Positive screen for alcohol or drugs of abuse (except for patients with a positive drug screen test if it is a result of a prescribed medication from their physician) at Screening and Check-in (Day -1).
8. History of a gout flare that is resolved within 14 days prior to first treatment with study drug (exclusive of chronic synovitis/arthritis).
9. Has a known hypersensitivity to URAT1 inhibitors, XOIs, or related compounds.
10. Receipt of any other investigational product within 30 days prior to the dose of study drug on Day 1or planning to take an investigational agent during the study.
11. Concomitant use of or treatment with any prescription drugs, herbal products, vitamins, minerals, and over-the-counter medications within 14 days prior to Check in (Day -1). Exceptions may be made on a case by case basis following discussion and agreement between the Investigator and the Sponsor.
12. Use of any drugs or nutrients known to modulate cytochrome P450 (CYP)3A activity or any strong or moderate inhibitors or inducers of CYP3A4, starting from 14 days prior to dose administration on Day 1 until the final end of study assessments, 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.
13. Participated in strenuous exercise from 48 hours prior to Check-in (Day -1) or during the study through the final end of study assessment.
14. Has donated or lost a significant volume (\>500 mL) of blood or plasma within 30 days prior to Check-in (Day -1).
15. Malignancy within 5 years of the screening visit.
16. 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.
17. Is unlikely to comply with the protocol requirements, instructions, and/or study related restrictions (e.g., uncooperative attitude, unavailable for follow up call, and/or improbability of completing the clinical study).
18 Years
75 Years
ALL
No
Sponsors
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Shanton Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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John M Hill, MD
Role: PRINCIPAL_INVESTIGATOR
Accel Research Sites (Avail Clinical Research)
Melanie Fein
Role: PRINCIPAL_INVESTIGATOR
High Point Clinical Trials Center
Peter Winkle
Role: PRINCIPAL_INVESTIGATOR
Anaheim Clinical Trials, LLC
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Avail - Accel Research Sites
DeLand, Florida, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Countries
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Other Identifiers
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SAP001-1-001
Identifier Type: OTHER
Identifier Source: secondary_id
SAP-001
Identifier Type: -
Identifier Source: org_study_id