Actively Recruiting
Pharmacokinetics, Safety, and Efficacy of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity - Phase I/IIa Study
Led by Ove Andersen · Updated on 2026-05-19
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ove Andersen
Lead Sponsor
U
University of Southern Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of fisetin, a compound that targets aging cells linked to chronic diseases and inflammation. This clinical trial includes healthy volunteers and older patients with multiple chronic health conditions to understand fisetin's absorption, metabolism, safety, and its impact on inflammation, aging cells, and overall health. The study combines Phase 1 and Phase 2a research to gather data for future larger trials. Participants will receive either fisetin at a dose of 20 mg/kg/day or a placebo for two consecutive days. The trial has two parts: an open-label study with healthy volunteers receiving fisetin and a randomized, triple-blind, placebo-controlled study with older patients receiving fisetin or placebo. Both groups will undergo three sub-studies focusing on pharmacokinetics, safety, and evaluation of potential health outcomes related to aging and inflammation. During the study, participants will be assessed at various time points over about three months. Researchers will monitor fisetin levels, adverse events, inflammation markers, aging biomarkers, physical and cognitive functions, and quality of life. Measurements include blood tests, frailty indexes, and cognitive assessments to evaluate the treatment's effects and safety. The study aims to identify meaningful outcomes for future research and ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 20 to 35 years
- suPAR levels below 3.5 ng/mL for healthy volunteers
- Ability to cooperate cognitively
- Ability to read and understand Danish
- Women of childbearing potential must use effective contraception
- Older patients acutely hospitalized, aged 65 years or older
- suPAR levels above 5 ng/mL for older patients
- Multimorbidity defined as two or more chronic diagnoses for older patients
- Ability to cooperate cognitively
- Ability to read and understand Danish
- Older patients must meet suPAR criteria 28 days after hospital discharge
You will not qualify if you...
- Body weight greater than 100 kg
- Inability to swallow pills
- Pregnancy or lactation
- Known allergy or hypersensitivity to fisetin or placebo ingredients
- Any condition that poses a risk or prevents successful study completion
- Presence of known chronic diagnosis (for healthy volunteers)
- Active acute illness
- Use of prescribed medication except contraceptives (for healthy volunteers)
- Previous cancer diagnosis or treatment (for healthy volunteers)
- Use of senolytic or anti-aging supplements
- Known HIV infection, active hepatitis B or C, or invasive fungal infection (older patients)
- Uncontrolled pleural/pericardial effusions or ascites (older patients)
- New or active invasive cancer except non-melanoma skin cancers (older patients)
- Active cancer treatment or disseminated cancer (older patients)
- Major immunodeficiency conditions (older patients)
- Use of medications affecting CYP3A4, CYP2D6, CYP2C9, CYP2C8 enzymes as judged clinically (older patients)
- Unstable major disorders including cardiovascular, renal, endocrine, immunological, hepatic, or cancer (older patients)
- Estimated glomerular filtration rate below 15 ml/min/1.73 m2 or as judged clinically (older patients)
- Elevated CRP above 30 mg/L at 28 days post-discharge (older patients)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants receive fisetin or placebo orally once daily for two consecutive days as part of the treatment.
1 baseline visit and multiple follow-up visits up to Day 3
Duration - Up to 12 weeks post-treatment
Participants undergo follow-up visits to assess safety, tolerability, pharmacokinetics, and various health outcomes including inflammation and aging biomarkers, physical and cognitive function, and quality of life.
Multiple visits on Days 8, 15, 29, 57, and 84 depending on participant group
Trial Site Locations
Total: 1 location
1
Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
J
Juliette Tavenier
L
Line Jee Hartmann Rasmussen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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