Fisetin for healthy young adults and older patients with multiple chronic conditions
Pharmacokinetics, Safety, and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study
This pilot will test a short two-day course of the senolytic compound fisetin in healthy young volunteers and hospitalized older patients with multiple chronic diseases to see how it is absorbed and whether it is safe.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06431932 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are healthy volunteers aged 20–35 with low suPAR levels and older medical patients aged 65 or older who are acutely hospitalized and have multiple chronic conditions.
Not a fit: People who are pregnant or lactating, weigh over 100 kg, have recent cancer, active acute infections, are taking excluded medications or other senolytics/anti‑aging supplements, or cannot comply with study visits are unlikely to receive benefit from this pilot.
Why it matters
Potential benefit: If successful, fisetin could reduce senescent cell burden and chronic inflammation and provide a foundation for larger trials that aim to improve multiple age-related conditions.
How similar studies have performed: Senolytic agents including fisetin have shown clear benefits in animal models and small human pilot studies of senolytics have reported promising safety and biomarker signals, but definitive clinical efficacy in humans remains unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hvidovre
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.