Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity

Launched by OVE ANDERSEN · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a substance called fisetin, which may help reduce chronic inflammation and eliminate old cells that can contribute to health problems as we age. The trial will involve healthy volunteers aged 20-35 and older patients aged 65 and above who have multiple chronic diseases. Participants will take fisetin or a placebo (a harmless pill with no active ingredients) for two days, and then they will be monitored for up to three months to see how their bodies respond to fisetin and whether it is safe to use.

To be eligible, healthy volunteers need to be between 20 and 35 years old and should have normal blood markers indicating they are in good health. Older patients must be at least 65 years old, hospitalized, and have at least two chronic health conditions. Participants will need to read and understand Danish, and certain health issues or medications may disqualify them from joining. Throughout the trial, participants can expect regular check-ups and assessments to track any changes in their health and the effects of fisetin. It’s important for everyone to understand that this is an early-stage study aimed at understanding the potential benefits of fisetin for health, particularly in older adults with multiple health issues.

Gender

ALL

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