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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Gout, Hyperuricemia

In brief

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.

Key facts

Study ID

NCT06729853

Run by

Shanton Pharma Pte. Ltd.

People needed

32

Starts

2024-04-24

Expected to finish

2025-04-28

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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)
• 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

Where it is running

• Genesis Clinical Research — Tampa, Florida, United States
• Nucleus Network Pty Ltd — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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