PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function (NCT06729853) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
United States32 participantsStarted 2024-04-24
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
maximum observed concentration (Cmax)
Timeframe: day 8
2
AUC from time 0 to time of last quantifiable sample (AUC0-T)
✕. 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