Fisetin for healthy young adults and older patients with multiple chronic conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial includes an open-label arm of 20 healthy volunteers given oral fisetin at 20 mg/kg/day for two consecutive days and a randomized, triple-blind placebo-controlled arm of 40 older medical patients who receive the same fisetin dosing or placebo for two days. Participants are followed with serial visits for up to three months to measure pharmacokinetics, safety, inflammation markers, senescent cell signals, and clinical measures of health. The study is organized into three sub-studies focused on pharmacokinetics, tolerability/safety, and identification of outcome measures for future larger trials. Data will be used to inform sample size calculations and feasibility for subsequent efficacy trials.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre
  Hvidovre, Denmark Recruiting

Study contacts

• Principal investigator: Ove Andersen — Copenhagen University Hospital, Amager and Hvidovre
• Study coordinator: Juliette Tavenier
• Email: juliette.tavenier@regionh.dk
• Phone: +4538620640

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.