GoutPhase 2NCT04040816
Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients
A Phase 2 study testing SAP-001 in people with Gout and Hyperuricemia, run by Shanton Pharma Co., Ltd. at 6 sites in United States.
Trial summary
This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients with Hyperuricemia. 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?
- SAP-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2019to 30 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female ≥ 18 and ≤ 75 years of age.
- Body mass index (BMI) ≥ 19 and ≤ 42 kg/m2 at screening.
- sUA levels ≥ 7.5 mg/dL during screening and at check-in (Day -1).
- Patients must meet the American College of Rheumatology scoring criteria for the classification of primary gout (Neogi et al 2015).
- Patients must be able to take gout flare prophylaxis with colchicine 0.6 mg QD throughout the study as the primary method to prevent disease flare. If colchicine is not tolerated or contraindicated, naproxen 250 mg BID with or without H2 antagonists will be employed as a second line gout flare prophylactic agent. Gout flare prophylaxis will be initiated at the Day -1 visit in patients who are sUA-lowering agent naïve. For patients that discontinue an sUA-lowering agent(s) (ie, washout from current therapy) during the screening period, gout flare prophylaxis should be initiated at the time of discontinuation of the sUA-lowering agent(s).
- Is a nonsmoker or light smoker (smokes fewer than 10 cigarettes per day).
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- Female patients either will 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 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, except those with documented surgical hysterectomy in medical history, will have a negative urine pregnancy test result prior to enrollment in the study.
- Male patients either will 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.
- Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
- Cohorts 1 through 3:
- Patients who are not taking any UA-lowering medications within 2 weeks prior to the dose of study drug. Patients may discontinue sUA-lowering agents (ie, washout from current therapy) during the screening period. In the cases of a patient who must discontinue sUA-lowering agents or a patient not previously taking sUA-lowering agents during the screening period, gout flare prophylaxis should be initiated with colchicine 0.6 mg QD as the primary method to prevent disease flare and be continued during the study period. If colchicine is not tolerated or contraindicated, naproxen 250 mg BID with or without H2 antagonists will be employed as a second line gout flare prophylactic agent.
- Cohort 4:
- Patient has been on a stable dose of allopurinol as existing urate-lowering therapy for at least 3 months prior to Day 1.
Who cannot join
- Female patient is pregnant, planning to get pregnant, or lactating/breastfeeding.
- 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.
- 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.
- History of stomach or intestinal surgery (except cholecystectomy, appendectomy, and/or hernia repair will be allowed).
- 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.
- Positive test for human immunodeficiency virus (HIV).
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- 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.
- 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.
- 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).
- 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.
- Has a known hypersensitivity to URAT1 inhibitors, XOIs, or related compounds.
- 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.
- 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).
- Participated in strenuous exercise from 48 hours prior to check-in (Day -1) or during the study through EOS.
- Has donated or lost a significant volume (> 500 mL) of blood or plasma within 30 days prior to check-in (Day -1).
- Malignancy within 5 years prior to the screening visit (excluding basal cell carcinoma).
- 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.
- 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:
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Anaheim Clinical Trials (ACT)
Anaheim, California, 92801
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Advanced Clinical Research
Meridian, Idaho, 83642
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Miami Research Associates
South Miami, Florida, 33143
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients With Hyperuricemia
This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients with Hyperuricemia.
Read the detailed description
This multiple dose study will include up to 4 cohorts. Each cohort will be comprised of 15 patients who will be dosed with SAP-001 or placebo once daily (QD) for 28 days. Dose escalation from Cohort 1 to Cohort 2 will occur after preliminary data are partially unblinded and safety data along with PK and PD parameters are analyzed and reviewed. Enrollment in Cohort 3 will begin after the last subject is randomized into Cohort 2.
Prior to starting enrollment into Cohort 4, a complete safety assessment of Cohorts 1, 2 and 3 will be performed to select the dose to be used in Cohort 4.
- Conditions
- Gout, Hyperuricemia
- Being tested
- SAP-001
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAP-001Drug
SAP-001 or placebo treatment in a 4:1 randomization ratio
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Experimental | Dose A SAP-001 versus placebo Receives: Drug: SAP-001 |
| Dose B | Experimental | Dose B SAP-001 versus placebo Receives: Drug: SAP-001 |
| Dose C | Experimental | Dose C SAP-001 versus placebo Receives: Drug: SAP-001 |
| Dose D (allopurinol patients) | Experimental | Dose D SAP-001 versus placebo in gout patients who remain on allopurinol Receives: Drug: SAP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Assess the safety and tolerability of multiple ascending doses of oral SAP-001 over 28 days compared to placebo
Measured: 28 days
Cmax
Maximum observed plasma concentration
Measured: 28 days
tmax
Time to maximum observed plasma concentration
Measured: 28 days
AUC0-t
Area under the plasma concentration-time curve from time 0 to time t
Measured: 28 days
AUC0-24h
Area under the plasma concentration-time curve from time 0 until 24 hours postdose
Measured: 28 days
AUC0-∞
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
Measured: 28 days
λz
Apparent terminal elimination rate constant
Measured: 28 days
t½
Terminal elimination phase half-life
Measured: 28 days
CL/F
Total body clearance
Measured: 28 days
Vz/F
Volume of distribution
Measured: 28 days
sUA
Serum urate concentration, change from baseline, and percent change from baseline
Measured: 28 days
Creatinine
Creatinine levels, change from baseline, and percent change from baseline
Measured: 28 days
Secondary outcomes (2)
Urate Lowering Effect
Assess the urate lowering effects of serum urate levels at various time points for multiple ascending doses of SAP-001 over 28 days compared to placebo
Measured: 28 days
Inflammation markers including cytokines IL-1β, IL-6, IL-8, and TNFα
Assess the effects of multiple ascending doses of SAP-001 on selected inflammation markers over 28 days compared to placebo
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Jan 2019
- Primary completion1 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanton Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Celina Cabale-Scholl, DPT, RN, Study chair, Shanton Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040816
- Sponsor's protocol ID
- SAP001-1-002
- Status last verified
- Nov 2021
- First submitted
- 17 Jul 2019
- Last updated
- 5 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT04040816
- Acronym / sponsor ID
- SAP001-1-002
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanton Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients with Hyperuricemia.
Detailed description
This multiple dose study will include up to 4 cohorts. Each cohort will be comprised of 15 patients who will be dosed with SAP-001 or placebo once daily (QD) for 28 days. Dose escalation from Cohort 1 to Cohort 2 will occur after preliminary data are partially unblinded and safety data along with PK and PD parameters are analyzed and reviewed. Enrollment in Cohort 3 will begin after the last subject is randomized into Cohort 2.
Prior to starting enrollment into Cohort 4, a complete safety assessment of Cohorts 1, 2 and 3 will be performed to select the dose to be used in Cohort 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose A | Experimental | Drug: SAP-001Dose A SAP-001 versus placebo |
| Dose B | Experimental | Drug: SAP-001Dose B SAP-001 versus placebo |
| Dose C | Experimental | Drug: SAP-001Dose C SAP-001 versus placebo |
| Dose D (allopurinol patients) | Experimental | Drug: SAP-001Dose D SAP-001 versus placebo in gout patients who remain on allopurinol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female ≥ 18 and ≤ 75 years of age.
- Body mass index (BMI) ≥ 19 and ≤ 42 kg/m2 at screening.
- sUA levels ≥ 7.5 mg/dL during screening and at check-in (Day -1).
- Patients must meet the American College of Rheumatology scoring criteria for the classification of primary gout (Neogi et al 2015).
- Patients must be able to take gout flare prophylaxis with colchicine 0.6 mg QD throughout the study as the primary method to prevent disease flare. If colchicine is not tolerated or contraindicated, naproxen 250 mg BID with or without H2 antagonists will be employed as a second line gout flare prophylactic agent. Gout flare prophylaxis will be initiated at the Day -1 visit in patients who are sUA-lowering agent naïve. For patients that discontinue an sUA-lowering agent(s) (ie, washout from current therapy) during the screening period, gout flare prophylaxis should be initiated at the time of discontinuation of the sUA-lowering agent(s).
Key exclusion criteria (20 listed)
- Female patient is pregnant, planning to get pregnant, or lactating/breastfeeding.
- 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.
- 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.
- History of stomach or intestinal surgery (except cholecystectomy, appendectomy, and/or hernia repair will be allowed).
- 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.
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 |
|---|---|---|
| SAP-001SAP-001 or placebo treatment in a 4:1 randomization ratio | Drug | Dose A, Dose B, Dose C, Dose D (allopurinol patients) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 days
Assess the safety and tolerability of multiple ascending doses of oral SAP-001 over 28 days compared to placebo
Cmax
Time frame: 28 days
Maximum observed plasma concentration
tmax
Time frame: 28 days
Time to maximum observed plasma concentration
AUC0-t
Time frame: 28 days
Area under the plasma concentration-time curve from time 0 to time t
AUC0-24h
Time frame: 28 days
Area under the plasma concentration-time curve from time 0 until 24 hours postdose
AUC0-∞
Time frame: 28 days
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
λz
Time frame: 28 days
Apparent terminal elimination rate constant
t½
Time frame: 28 days
Terminal elimination phase half-life
CL/F
Time frame: 28 days
Total body clearance
Vz/F
Time frame: 28 days
Volume of distribution
sUA
Time frame: 28 days
Serum urate concentration, change from baseline, and percent change from baseline
Creatinine
Time frame: 28 days
Creatinine levels, change from baseline, and percent change from baseline
2 secondary outcomes
Urate Lowering Effect
Time frame: 28 days
Inflammation markers including cytokines IL-1β, IL-6, IL-8, and TNFα
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Celina Cabale-Scholl, DPT, RN study chair
Shanton Pharma
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAP-001 in people with Gout and Hyperuricemia, run by Shanton Pharma Co., Ltd. at 6 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 13 inclusion and 20 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 28 days). The study lists 12 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 5 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.