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GoutPhase 1/2NCT06729853

PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function

A Phase 1/2 study testing SAP-001 in people with Gout and Hyperuricemia, run by Shanton Pharma Pte. Ltd. at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Gout, Hyperuricemia
What is being tested?
SAP-001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
24 Apr 2024to 28 Apr 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All subjects:
  • Provision of signed and dated informed consent form (ICF)
  • Subject is, as stated and in the opinion of the Investigator, willing and able to comply with the study drug regimen and all other protocol and study procedures and requirements, and is available for the duration of the study
  • Adult male or female
  • Subject is willing to comply with the contraceptive requirements as defined in APPENDIX 6
  • Aged at least 18 years but not older than 80 years
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  • BMI ≥ 18.5 kg/m2 and < 42.0 kg/m2 at the time of Screening.
  • Light-, non- or ex-smoker (A light smoker is defined as someone using 10.0 nicotine units [1 unit = 1 cigarette] or less per day for at least 90 days prior to study drug administration. An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to study drug administration)
  • Having suitable venous access for blood sampling
  • Subjects with Normal Renal Function (Group 4):
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the laboratory tests, physical examination (including vital signs) and/or ECG, as determined by an Investigator
  • Normal renal function with estimated glomerular filtration rate (eGFR) ≥ 90 mL/minute at Screening
  • Must match to the pooled mean age (± 10 years), BMI (within 20%) and sex (ratio should be similar) of mild, moderate (if applicable), and severe (if applicable) renal impaired subjects
  • Subjects with mild, moderate, or severe renal impairment (Groups 1, 2 and 3, respectively):
  • Considered clinically stable in the opinion of an Investigator
  • Presence of mild renal impairment (eGFR ≥ 60 and < 90 mL/min), moderate renal impairment (eGFR ≥ 30 and < 60 mL/min) or severe renal impairment (eGFR≥ 15 and < 30 mL/min) at Screening. Renal impairment should be stable for at least 1 month prior to Screening (change in eGFR should not be more than 25%).
  • Note: The Investigator can order a repeat of eGFR if it is determined that the initial value is inconsistent with the historical values for a particular subject

Who cannot join

  • All subjects:
  • Female who is lactating
  • Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration
  • History of significant hypersensitivity to SAP-001 or any related products (including excipients of the formulation) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • Positive screening results to HIV Ag/Ab Combo and Hepatitis B surface antigen (HBsAg)
  • Positive reflex test for Hepatitis C antibody (positive Hepatitis C antibody is allowed if HCV RNA is not detected)
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  • Presence or history of any disorder that could interfere with completion of the study based on the opinion of an Investigator
  • Intake of SAP-001 or any Investigational Product (IP) in the 28 days (or 5 times the half-life of the drug, whichever is longer) prior to study drug administration
  • Have urinary incontinence without catheterization
  • Reception of blood products within 3 months prior to study drug administration
  • Donation of 50 mL or more of blood in the 28 days prior to Screening
  • Donation of 500 mL or more of blood within 56 days prior to Screening.
  • Donation of plasma within 2 weeks prior to Screening or platelets within 6 weeks prior to Screening
  • Inclusion in a previous group for this clinical study
  • Subjects with Normal Renal Function (Group 4):
  • Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects
  • History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
  • Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  • Presence of out-of-range cardiac interval (eg, QTcF > 440 msec) based on the mean of the triplicate ECG values at Screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator
  • Positive test result for alcohol and/or drugs of abuse at Screening or prior to study drug administration
  • Seated blood pressure below 90/60 mmHg at Screening and prior to dosing
  • Seated blood pressure higher than 140/90 mmHg at Screening and prior to dosing
  • Seated pulse rate less than 40 beats per minutes (bpm) or more than 100 bpm at Screening and prior to dosing
  • Any clinically significant illness in the 28 days prior to study drug administration
  • Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration that, in the opinion of an Investigator, would put into question the status of the participant as healthy
  • Use of St. John's wort in the 28 days prior to study drug administration
  • Use of over-the-counter drugs and natural health products (eg, herbal remedies) in the 14 days (or 5 times the half-life of the drug, whichever is longer) prior to study drug administration
  • Use of any enzyme-modifying drugs, or drugs with effects on membrane transporters, including any strong cytochrome P450 3A4 and P-glycoprotein inducers and inhibitors in the previous 28 days prior to study drug administration
  • Subjects with Renal Impairment (Groups 1, 2 and 3):
  • History of renal transplant
  • Seated blood pressure below 100/50 mmHg at Screening and prior to dosing
  • Seated blood pressure higher than 180/100 mmHg at Screening and prior to dosing
  • Seated pulse rate less than 50 bpm or more than 110 bpm at Screening and prior to dosing
  • History or presence, in the opinion of an Investigator, of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  • Presence of poorly controlled Type 1 or Type 2 diabetes as defined by hemoglobin A1c > 10%
  • Presence of clinically significant physical examination, laboratory test, or ECG finding that, in the opinion of an Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
  • Subjects requiring treatment for renal impairment or other chronic disease (eg, well-controlled diabetes, hypertension) must be on a stable treatment plan (medicines, doses, and regimens) for at least 14 days (except insulin) prior to study drug administration and during the entire study. Small adjustments in the dosages of some concomitant medications may be permitted during the study and will be discussed on a case-by-case basis. In all cases, the subjects' treatment history must be reviewed and their enrollment must be agreed to by both an Investigator and the Sponsor's Medical Monitor
  • Positive screening of alcohol and/or drugs of abuse at Screening or prior to study drug administration unless results can be explained by a prescription medication
  • Concurrent use of medications known to affect the elimination of serum creatinine (eg, trimethoprim/sulfamethoxazole [Bactrim®] or cimetidine [Tagamet®]) and competitors of renal tubular secretion (eg, probenecid) within 30 days prior to study drug administration or anticipated need for these therapies through to the last PK sample of the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Nucleus Network Pty Ltd

    Saint Paul, Minnesota, 55114

  • Genesis Clinical Research

    Tampa, Florida, 33603

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of SAP-001 in Adult Subjects With Normal and Impaired Renal Function

This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function.

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

    a single oral dose of SAP-001

Study groups in NCT06729853
Study groupRoleWhat they receive
Mild renal impairmentExperimentalSubjects with mild renal impairment
Receives: Drug: SAP-001
Moderate renal impairmentExperimentalSubjects with moderate renal impairment
Receives: Drug: SAP-001
Severe renal impairmentExperimentalSubjects with severe renal impairment(Optional)
Receives: Drug: SAP-001
Healthy matchExperimentalMatched healthy subjects with normal renal function
Receives: Drug: SAP-001

What is being measured

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

  1. maximum observed concentration (Cmax)

    The primary PK endpoints

    Measured: day 8

  2. AUC from time 0 to time of last quantifiable sample (AUC0-T)

    The primary PK endpoints

    Measured: day 8

  3. apparent clearance (CL/F)

    The primary PK endpoints

    Measured: day 8

Secondary outcomes (7)

  1. time to maximum concentration (Tmax)

    Plasma PK parameters

    Measured: day 8

  2. AUC from time 0 extrapolated to infinity (AUC0-∞)

    Plasma PK parameters

    Measured: day 8

  3. terminal elimination half-life (Thalf)

    Plasma PK parameters

    Measured: day 8

  4. volume of distribution (Vz/F)

    Plasma PK parameters

    Measured: day 8

  5. Ae(0-T) (amount excreted)

    Urine PK parameters:

    Measured: day 8

  6. Fraction of dose excreted in urine (fe)

    Urine PK parameters:

    Measured: day 8

  7. CLr (renal clearance)

    Urine PK parameters:

    Measured: day 8

Timeline

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

  1. First posted11 Dec 2024
  2. Study start24 Apr 2024
  3. Primary completion17 Jan 2025 (estimated)
  4. Study completion28 Apr 2025 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06729853
Sponsor's protocol ID
SAP-001-104
Status last verified
Dec 2024
First submitted
4 Dec 2024
Last updated
11 Dec 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SAP-001 in people with Gout and Hyperuricemia, run by Shanton Pharma Pte. Ltd. at 2 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 17 inclusion and 39 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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?

maximum observed concentration (Cmax) (time frame: day 8). The study lists 3 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 NCT06729853.

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 11 Dec 2024.

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