Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT06431932
Eligibility Criteria:
Healthy volunteers:
Inclusion Criteria:
* Aged 20-35 years
* suPAR levels \<3.5 ng/mL (± 15% corresponding to assay variation)
* Able to cooperate cognitively
* Able to read and understand Danish
* Women of childbearing potential must use effective contraception
Exclusion Criteria:
* Body weight \>100 kg
* Inability to swallow pills
* Pregnant and/or lactating
* Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
* Presence of any condition that the investigator believes would put the subject at risk or would preclude the participant from successfully completing all aspects of the trial
* Presence of known chronic diagnosis
* Active acute illness
* Prescribed medication, except contraceptives
* Previous cancer diagnosis or treatment
* Use of senolytic and other "anti-aging" supplements
Older patients with multimorbidity:
Inclusion Criteria:
At screening #1 during hospital admission:
* Acutely hospitalized medical patient
* Age ≥65 years
* suPAR \>5 ng/mL (± 15% corresponding to assay variation)
* Multimorbidity (≥2 chronic diagnoses)
* Able to cooperate cognitively
* Able to read and understand Danish
At screening #2 28 days after hospital discharge:
* suPAR \>5 ng/mL (± 15% corresponding to assay variation)
Exclusion Criteria:
At screening #1 during hospital admission:
* Body weight \>100 kg
* Inability to swallow pills
* Known human immunodeficiency virus infection, active hepatitis B or C infection, invasive fungal infection
* Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites
* New/active invasive cancer except non-melanoma skin cancers
* Active cancer treatment or disseminated cancer
* Known condition associated with major immunodeficiency
* Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
* Use of senolytic and other "anti-aging" supplements
At screening #2 28 days after hospital discharge:
* Body weight \>100 kg
* CRP \>30 mg/L (± 15% corresponding to assay variation)
* Inability to swallow pills
* Presence of any condition, or abnormal routine biochemistry test, that the investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial
* Unstable (as per clinical judgment) major disorders, e.g., cardiovascular, renal, endocrine, immunological, hepatic disorder, or cancer
* Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 or as per clinical judgment (e.g., risk of acute kidney injury)
* Human immunodeficiency virus infection, known active hepatitis B or C infection, invasive fungal infection
* Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites
* New/active invasive cancer except non-melanoma skin cancers
* Active cancer treatment or disseminated cancer
* Known condition associated with major immunodeficiency
* Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
* Subjects taking strong inhibitors or inducers of CYP3A4 or as per clinical judgment
* Subjects taking specified substrates with a narrow therapeutic range for CYP3A4 or as per clinical judgment
* Subjects taking specified inhibitors, inducers, or substrates of CYP2D6, CYP2C9, or CYP2C8, or as per clinical judgment
* Subjects regularly using drug classes or specific medications or as per clinical judgment
* Use of senolytic and other "anti-aging" supplements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT06431932
Study Brief:
Protocol Section:
NCT06431932