Fisetin absorption and clearance in young versus older adults
A Comparison of Fisetin Kinetics in Young and Old Adults - FISEKIN-1
This test will measure how a single oral dose of fisetin is absorbed and cleared in healthy young adults (18–30) and older adults (65+) when taken fasting or with a high‑fat meal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medicine Greifswald Academic / other |
| Locations | 1 site (Greifswald) |
| Trial ID | NCT06796374 on ClinicalTrials.gov |
What this trial studies
This open-label, two-cohort, four-arm crossover protocol gives each participant a single 500 mg oral dose of fisetin in random order under both fasted and standardized high‑fat fed conditions, with at least a one-week washout between visits. Each participant undergoes intensive pharmacokinetic sampling with 24 blood draws over 10 hours after dosing and urine collection for metabolite analysis. The fed condition follows an FDA-recommended high‑calorie, high‑fat meal to assess food effects on absorption. Primary comparisons will quantify standard PK parameters (Cmax, Tmax, AUC, half‑life) between young (18–30) and older (≥65) cohorts and between fed and fasted states.
Who should consider this trial
Good fit: Healthy volunteers aged 18–30 or 65 and older who can give informed consent, meet BMI and weight criteria, take no more than three chronic medications, and have no significant liver, kidney, cardiac, or psychiatric disorders are ideal candidates.
Not a fit: People with BMI outside 18–30 kg/m2, low body weight, pregnancy or lactation, significant liver or renal impairment, prolonged QTc, active psychiatric disease, heavy recreational drug use, or known hypersensitivity to fisetin are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify whether older adults need different dosing or administration advice for fisetin and guide safer, more effective use in later clinical studies.
How similar studies have performed: Age-comparison and food-effect pharmacokinetic studies are a standard and successful approach for other oral drugs, but fisetin-specific PK data—especially in older adults—are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * any sex * age between 18 and 30 years or ≥ 65 years * understands the study purpose and design * contractually capable and provides signed informed consent form * healthy condition or mild and/or well-treated forms of allergies, asthma, hypertension, and orthopedic diseases * a maximum of 3 chronically taken drugs Exclusion Criteria: * BMI \> 30 kg/m2 and \< 18 kg/m2 * body weight \< 48 kg * women in young cohort: known pregnancy or lactation period; positive urine pregnancy test at screening or kinetic visit * men: hemoglobin \< 8,3 mmol/l women: hemoglobin \< 7,3 mmol/l * elevated liver function tests (1 or more of ALAT, ASAT, yGT, Bilirubin \> 2x ULN) * reduced renal function (eGFRMDRD \< 60 ml/min/1,7 m2) * QTcF \> 450 ms in screening ECG * psychiatric disease requiring recent or actual treatment * drug dependency at the time of visit * use of recreational drugs more than twice a week * any known hypersensitivity or allergic reactions to fisetin * history of severe hypersensitivity reactions and/or anaphylaxis * poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it * intake of drugs undergoing extensive metabolism via CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and/or Pgp and with narrow (monitoring-requiring) therapeutic range during the past seven days if the duration of intake was at least two days * intake of COMT-inhibitors during the past seven days if the duration of intake was at least two days * intake of drugs or dietary supplements containing fisetin within the two days before or during the kinetic visits * individuals who have eaten food with high fisetin content in the two days before the kinetic visits (e.g. strawberry, apple, persimmon, grape, mango, kiwi, peach, tomato, onion, lotus roots, kale, cucumber; processed products, e.g. wine)
Where this trial is running
Greifswald
- Department of Clinical Pharmacology, Institute of Pharmacology at the Center of Drug Absorption and Transport (C_DAT), University Medicine Greifswald — Greifswald, Germany (Recruiting)
Study contacts
- Study coordinator: Stefan Engeli, Prof.
- Email: stefan.engeli@med.uni-greifswald.de
- Phone: +49 3834 86 56 33
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.