New treatment option for Pharmacokinetic Study in Healthy Volunteers
Official title A Comparison of Fisetin Kinetics in Young and Old Adults
ClinicalTrials.gov ID: NCT06796374
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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)
See the full eligibility 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
- 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 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...
The study team makes the final eligibility decision.
Where it's taking place
- Greifswald, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greifswald, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.