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A Comparison of Fisetin Kinetics in Young and Old Adults

RecruitingNAAges 18 Years - anyAllUniversity Medicine Greifswald
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In plain words

What the trial is, and whether it could suit you

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), f

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * any sex * age between 18 and 30 years or โ‰ฅ 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)
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What it tests

  • Fisetin - Fasted condition
  • Fisetin - Fed condition
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Where

1 site
Department of Clinical Pharmacology, Institute of Pharmacology at the Center of Drug Absorption and Transport (C_DAT), University Medicine Greifswald
Greifswald, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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