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

NCT06729853 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SAP-001-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (3)

• maximum observed concentration (Cmax)

  The primary PK endpoints

  day 8

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

  The primary PK endpoints

  day 8

• apparent clearance (CL/F)

  The primary PK endpoints

  day 8

Secondary Outcomes (7)

• time to maximum concentration (Tmax)

  day 8

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

  day 8

• terminal elimination half-life (Thalf)

  day 8

• volume of distribution (Vz/F)

  day 8

• Ae(0-T) (amount excreted)

  day 8

Study Arms (4)

Mild renal impairment

EXPERIMENTAL

Subjects with mild renal impairment

Drug: SAP-001

Moderate renal impairment

EXPERIMENTAL

Subjects with moderate renal impairment

Drug: SAP-001

Severe renal impairment

EXPERIMENTAL

Subjects with severe renal impairment(Optional)

Drug: SAP-001

Healthy match

EXPERIMENTAL

Matched healthy subjects with normal renal function

Drug: SAP-001

Interventions

SAP-001 DRUG

a single oral dose of SAP-001

Healthy match; Mild renal impairment; Moderate renal impairment; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

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
• 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

Sponsors & Collaborators

• Shanton Pharma Pte. Ltd.: lead

Study Sites (2)

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

Nucleus Network Pty Ltd

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: April 24, 2024
• Primary Completion: January 17, 2025
• Study Completion: April 28, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

US (2)