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Gout, HyperuricemiaPhase 1NCT03857165

Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients

A Phase 1 study testing SAP-001 in people with Gout, Hyperuricemia, run by Shanton Pharma Co., Ltd. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy 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
24 participants
Where
3 sitesUnited States
Study dates
24 Sep 2018to 31 Oct 2019
Phase
Phase 1
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, between 18 and 75 years of age, inclusive.
  • Body mass index (BMI) between 19 and 42 kg/m^2 at screening, inclusive.
  • Serum uric acid (sUA) levels ≥7.5 mg/dL at screening.
  • Patients must meet all the American College of Rheumatology scoring criteria for the classification of primary gout (Neogi et al., 2015).
  • Patients who are not taking any UA-lowering medications 1 month prior to the dose of study drug.
  • Is a nonsmoker or light smoker (smokes fewer than 10 cigarettes per day).
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  • 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.
  • 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.
  • Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.

Who cannot join

  • Has a history or presence of clinically significant (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 (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)
  • History of stomach or intestinal surgery (except that 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 blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C (HCV) antibody.
  • 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.
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  • 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).
  • History of a gout flare that is resolved within 14 days prior to first treatment with study drug (exclusive of chronic synovitis/arthritis).
  • Has a known hypersensitivity to URAT1 inhibitors, XOIs, or related compounds.
  • 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.
  • 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.
  • 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.
  • Participated in strenuous exercise from 48 hours prior to Check-in (Day -1) or during the study through the final end of study assessment.
  • 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 of the screening visit.
  • 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 (e.g., uncooperative attitude, unavailable for follow up call, and/or improbability of completing the clinical study).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Avail - Accel Research Sites

    DeLand, Florida, 32720

  • High Point Clinical Trials Center

    High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients With Hyperuricemia

This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients with Hyperuricemia. The study will be single dose ascending cohorts across three doses with a placebo control arm.

Read the detailed description

A total of 24 eligible adult subjects will be randomized in a 3:1 randomization ratio into two blinded treatment groups in the three dose cohorts with matching placebo arm. The duration of the observation would be 5 days for each subject with a single SAP-001 dosing to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of oral SAP-001 (once daily) in adults gout patients with 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 3:1 randomization ratio.

Study groups in NCT03857165
Study groupRoleWhat they receive
Low dose SAP-001ExperimentalSAP-001 (Experimental drug) low dose versus placebo
Receives: Drug: SAP-001
Mid dose SAP-001ExperimentalSAP-001 (Experimental drug) mid dose versus placebo
Receives: Drug: SAP-001
High dose SAP-001ExperimentalSAP-001 (Experimental drug) high dose versus placebo
Receives: Drug: SAP-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Safety and tolerability of single escalating dose SAP-001

    Measured: 5 days

  2. Cmax

    Maximum Plasma Concentration of SAP-001 in ng/mL

    Measured: 5 days

  3. tmax

    Time to maximum concentration in hours

    Measured: 5 days

  4. AUC0-t

    Area under the concentration-time curve from time 0 to time t, calculated using the linear trapezoidal rule for increasing values, and the log trapezoidal rule for decreasing values

    Measured: 5 days

  5. AUC0-24h

    Area under the concentration-time curve from time 0 until 24 hours post dose, calculated using the linear trapezoidal rule for increasing values, and the log trapezoidal rule for decreasing values

    Measured: 24 hours

  6. λz

    Apparent terminal elimination rate constant

    Measured: 5 days

  7. t1/2

    Terminal elimination phase half-life of SAP-001, calculated as ln(2)/λz

    Measured: 5 days

  8. CL/F

    Total body clearance of SAP-001, calculated as Dose/AUC0-∞

    Measured: 5 days

  9. Vz/F

    Volume of distribution of SAP-001

    Measured: 5 days

  10. MRT

    Mean residence time in hours

    Measured: 5 days

Secondary outcomes (5)

  1. Serum uric acid (sUA) levels at various time points

    Serum uric acid (sUA) levels in mg/dL at various time points after oral administration of ascending single dose of SAP-001 or placebo

    Measured: 72 hours

  2. IL-1β

    Inflammatory cytokine IL-1β in pg/mL

    Measured: 24 hours

  3. IL-6

    Inflammatory cytokine IL-6 in pg/mL

    Measured: 24 hours

  4. IL-8

    Inflammatory cytokine IL-8 in pg/mL

    Measured: 24 hours

  5. TNFα

    Inflammatory cytokine TNFα in pg/mL

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2019
  2. Study start24 Sep 2018
  3. Primary completion2 Jun 2019
  4. Study completion31 Oct 2019

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Single ascending dose with placebo control
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857165
Sponsor's protocol ID
SAP-001
Other IDs
SAP001-1-001
Status last verified
Nov 2019
First submitted
18 Oct 2018
Last updated
14 Oct 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAP-001 in people with Gout, Hyperuricemia, run by Shanton Pharma Co., Ltd. at 3 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 9 inclusion and 17 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 5 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857165.

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 14 Oct 2021.

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