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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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
. 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