A Comparison of Fisetin Kinetics in Young and Old Adults

Recruiting now · Not applicable

Conditions studied: Pharmacokinetic Study in Healthy Volunteers

In brief

This study investigates the differences in the kinetic parameters of fisetin in two cohorts of healthy volunteers: Cohort 1) volunteers aged 18-30 years (n = 40) Cohort 2) volunteers aged 65 years or older (n = 40) The purpose of this study is: 1. To describe the fisetin kinetics after a single dose oral administration in older age. 2. To compare the fisetin kinetics after a single dose oral administration in old and young age. FISEKIN-1 is designed as a four-arm study protocol. As well as two different age groups (18-30 years vs. 65 years and older), we want to compare fisetin kinetic parameters in fasted and fed condition: Arm 1) 500 mg fisetin (1x 5 capsule), fasted condition, cohort 1: young age Arm 2) 500 mg fisetin (1x 5 capsule), fasted condition, cohort 2: old age Arm 3) 500 mg fisetin (1x 5 capsule), fed condition, cohort 1: young age Arm 4) 500 mg fisetin (1x 5 capsule), fed condition, cohort 2: old age

Key facts

Study ID: NCT06796374
Run by: University Medicine Greifswald
People needed: 80
Starts: 2026-03-31
Expected to finish: 2027-07-31
Last updated by the study team: 2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Department of Clinical Pharmacology, Institute of Pharmacology at the Center of Drug Absorption and Transport (C_DAT), University Medicine Greifswald — Greifswald, Germany (enrolling)

Full record on ClinicalTrials.gov

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