MultimorbidityPhase 1/2Fisetin HIGHNCT06431932
Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
A Phase 1/2 study testing Fisetin in people with Multimorbidity and Healthy, run by Ove Andersen at 1 site in Denmark.
Trial summary
The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multimorbidity, Healthy
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Mar 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20-35 years
- suPAR levels <3.5 ng/mL (± 15% corresponding to assay variation)
- Able to cooperate cognitively
- Able to read and understand Danish
- Women of childbearing potential must use effective contraception
- At screening #1 during hospital admission:
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- Acutely hospitalized medical patient
- Age ≥65 years
- suPAR >5 ng/mL (± 15% corresponding to assay variation)
- Multimorbidity (≥2 chronic diagnoses)
- Able to cooperate cognitively
- Able to read and understand Danish
- At screening #2 28 days after hospital discharge:
- suPAR >5 ng/mL (± 15% corresponding to assay variation)
Who cannot join
- Body weight >100 kg
- Inability to swallow pills
- Pregnant and/or lactating
- Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
- Presence of any condition that the investigator believes would put the subject at risk or would preclude the participant from successfully completing all aspects of the trial
- Presence of known chronic diagnosis
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- Active acute illness
- Prescribed medication, except contraceptives
- Previous cancer diagnosis or treatment
- Use of senolytic and other "anti-aging" supplements
- Older patients with multimorbidity:
- At screening #1 during hospital admission:
- Body weight >100 kg
- Inability to swallow pills
- Known human immunodeficiency virus infection, active hepatitis B or C infection, invasive fungal infection
- Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites
- New/active invasive cancer except non-melanoma skin cancers
- Active cancer treatment or disseminated cancer
- Known condition associated with major immunodeficiency
- Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
- Use of senolytic and other "anti-aging" supplements
- At screening #2 28 days after hospital discharge:
- Body weight >100 kg
- CRP >30 mg/L (± 15% corresponding to assay variation)
- Inability to swallow pills
- Presence of any condition, or abnormal routine biochemistry test, that the investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial
- Unstable (as per clinical judgment) major disorders, e.g., cardiovascular, renal, endocrine, immunological, hepatic disorder, or cancer
- Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m2 or as per clinical judgment (e.g., risk of acute kidney injury)
- Human immunodeficiency virus infection, known active hepatitis B or C infection, invasive fungal infection
- Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites
- New/active invasive cancer except non-melanoma skin cancers
- Active cancer treatment or disseminated cancer
- Known condition associated with major immunodeficiency
- Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
- Subjects taking strong inhibitors or inducers of CYP3A4 or as per clinical judgment
- Subjects taking specified substrates with a narrow therapeutic range for CYP3A4 or as per clinical judgment
- Subjects taking specified inhibitors, inducers, or substrates of CYP2D6, CYP2C9, or CYP2C8, or as per clinical judgment
- Subjects regularly using drug classes or specific medications or as per clinical judgment
- Use of senolytic and other "anti-aging" supplements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre
Hvidovre, 2650
Juliette Tavenier, +45 38620640, juliette.tavenier@regionh.dk
Line Jee Hartmann Rasmussen, +45 38620640, line.jee.hartmann.rasmussen@regionh.dk
About this study
Official title: Pharmacokinetics, Safety, and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study
The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models.
We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health.
Read the detailed description
The goal of this pilot trial is to conduct a controlled clinical study to gather data on the pharmacokinetic profile of fisetin and its metabolites and on the safety and tolerability of fisetin in healthy volunteers as well as in older medical patients. Furthermore, we aim to identify potential outcome measures and perform sample size calculations for these outcomes, with the intent to conduct a larger scale effect study, at later date, given the result from this pilot study suggests that this would be feasible and safe.
The trial consists of:
- a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
- a 2-arm triple-blind randomized placebo-controlled study, in which older medical patients (n=40) will receive either:
- 20 mg/kg/day fisetin for two consecutive days, or
- placebo for two consecutive days.
Each of the studies (open-label study and randomized placebo-controlled study) consists of three sub-studies:
- Sub-study I aims to investigate the pharmacokinetic properties of fisetin and its main metabolites following oral administration at a dose of 20 mg/kg/day in healthy volunteers and in older medical patients.
- Sub-study II aims to assess the safety and tolerability of oral treatment with fisetin at a dose of 20 mg/kg/day fisetin for two consecutive days in healthy volunteers and in older medical patients.
- Sub-study III aims to gather representative measurements to assess the utility of inflammation, SASP, senescence, senolysis, and aging biomarkers, as well as measures of frailty, clinical parameters, physical and cognitive function, and quality of life as potential outcomes in future clinical trials; additionally, to perform sample size calculations for future trials based on these data.
- Conditions
- Multimorbidity, Healthy
- Being tested
- Fisetin, Placebo
- Keywords
- Senolytic, Pharmacokinetics, Chronic inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDrug
Subjects will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
PlaceboDrug
Subjects will receive a corresponding number of placebo capsules for two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm open-label study in healthy volunteers | Experimental | Healthy volunteers will receive fisetin. Receives: Drug: Fisetin |
| RCT - Treatment group | Experimental | Older patients with multimorbidity will receive fisetin. Receives: Drug: Fisetin |
| RCT - Placebo group | Placebo comparator | Older patients with multimorbidity will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population-based pharmacokinetic model for fisetin and metabolites
To develop a population-based pharmacokinetic (popPK) model for fisetin and its main metabolites in healthy volunteers and older patients, covariates such as body weight, body composition, age, and CYP inducers/inhibitors will be tested for influence on interindividual variability.
Measured: 24 hours
Adverse events
Number of participants to experience adverse events
Measured: Day 1 to 3
suPAR
The change in plasma levels of suPAR and a sample size calculation based on these data.
Measured: Day 1 to 29
Secondary outcomes (15)
Population-based PKPD model for fisetin
Changes in any of the measured biomarkers and the relationship between the pharmacokinetics and pharmacodynamics of fisetin will be investigated using population PKPD modeling.
Measured: 24 hours
Renal excretion of fisetin and its main metabolites
Urinary levels of fisetin and its main metabolites
Measured: 24 hours
Symptoms and adverse events
Number of participants to experience symptoms and clinically significant changes in vital signs (i.e., blood pressure, pulse).
Measured: Day 1 to 3
SASP factors and inflammation markers
The change in plasma levels of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors).
Measured: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Senescence
The change in expression levels of senescence markers (e.g., p16INK4a, p21CIP1/WAF1, SA-B-gal) in immune cells and tissue biopsies (skin and adipose tissue).
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 8, 15, 29, 84.
Senolysis
The change in expression levels of senolysis markers (e.g., leukotriene B4, dihomo-15d-PGJ2 (oxylipin or 1a,1b-dihomo-15-deoxy-D12,14-prostaglandin J2), and 15-Deoxy-delta 12, 14-prostaglandin J2).
Measured: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 84.
Aging markers
The change in plasma levels of aging markers (e.g., α-klotho, fibroblast growth factor 21).
Measured: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Clinical markers
The change in levels of routine biochemistry markers (e.g., alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, coagulation factors II, VII and X and International Normalized Ratio, CRP, creatinine, hemoglobin, lactate dehydrogenase, mean corpuscular hemoglobin concentration, mean corpuscular volume, neutrophils, potassium, sodium, thrombocytes, white blood cell count, cholesterol (total, low-density lipoproteins, high-density lipoproteins), triglycerides, and hemoglobin A1c).
Measured: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Frailty Index OutRef
The change in frailty status calculated as Frailty Index OutREF (FI-OutRef).
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Frailty Index
The change in frailty status calculated using a modified version of Fried frailty criteria.
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Physical function
The change in physical function (e.g., gait speed, hand grip strength, chair stand test, balance).
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Cognitive function (Montreal Cogntive Assessment)
The change in cognitive function assessed using the MoCA score (0-30 with higher scores representing better cognitive function).
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Cognitive function (Digit Symbol Substitution Test)
The change in cognitive function assessed using the Digit Symbol Substitution Test (number of correct symbols).
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Quality of life
The change in quality of life assessed using the EuroQol-5D-5L (index value and VAS scale 0-100; with higher scores representing better quality of life).
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Self-rated health
The change in self-rated health (score 1-5; 1:"excellent", 2:"very good", 3:"good", 4:"fair", or 5:"bad").
Measured: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start24 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial consists of: * a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days. * a 2-arm triple-blind randomized placebo-controlled study, in which older patients with multimorbidity (n=40) will receive either: * 20 mg/kg/day fisetin for two consecutive days, or * placebo for two consecutive days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ove Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Mayo Clinic
- Responsible party
- Sponsor-investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Juliette Tavenier, Study chair, Copenhagen University Hospital, Amager and HvidovreLine Jee Hartmann Rasmussen, Study chair, Copenhagen University Hospital, Amager and HvidovreMorten B Houlind, Study chair, Copenhagen University Hospital, Amager and HvidovreOve Andersen, Principal investigator, Copenhagen University Hospital, Amager and HvidovreJan O Nehlin, Study chair, Copenhagen University Hospital, Amager and Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431932
- Sponsor's protocol ID
- Fisetin HIGH
- Other IDs
- 2023-506284-34-00, 2023
- Acronym
- Fisetin HIGH
- Status last verified
- May 2026
- First submitted
- 15 May 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data can be available for other researchers due to Danish Data Protection Law.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety, and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study
- ClinicalTrials.gov ID
- NCT06431932
- Acronym / sponsor ID
- Fisetin HIGH / Fisetin HIGH
- Conditions
- Multimorbidity, Healthy
- Keywords
- Senolytic, Pharmacokinetics, Chronic inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ove AndersenUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Mayo Clinic
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models.
We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health.
Detailed description
The goal of this pilot trial is to conduct a controlled clinical study to gather data on the pharmacokinetic profile of fisetin and its metabolites and on the safety and tolerability of fisetin in healthy volunteers as well as in older medical patients. Furthermore, we aim to identify potential outcome measures and perform sample size calculations for these outcomes, with the intent to conduct a larger scale effect study, at later date, given the result from this pilot study suggests that this would be feasible and safe.
The trial consists of:
- a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
- a 2-arm triple-blind randomized placebo-controlled study, in which older medical patients (n=40) will receive either:
- 20 mg/kg/day fisetin for two consecutive days, or
- placebo for two consecutive days.
Each of the studies (open-label study and randomized placebo-controlled study) consists of three sub-studies:
- Sub-study I aims to investigate the pharmacokinetic properties of fisetin and its main metabolites following oral administration at a dose of 20 mg/kg/day in healthy volunteers and in older medical patients.
- Sub-study II aims to assess the safety and tolerability of oral treatment with fisetin at a dose of 20 mg/kg/day fisetin for two consecutive days in healthy volunteers and in older medical patients.
- Sub-study III aims to gather representative measurements to assess the utility of inflammation, SASP, senescence, senolysis, and aging biomarkers, as well as measures of frailty, clinical parameters, physical and cognitive function, and quality of life as potential outcomes in future clinical trials; additionally, to perform sample size calculations for future trials based on these data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The trial consists of: * a single-arm open-label study, in which healthy volunteers (n=20) will receive fisetin corresponding to 20 mg/kg/day for two consecutive days. * a 2-arm triple-blind randomized placebo-controlled study, in which older patients with multimorbidity (n=40) will receive either: * 20 mg/kg/day fisetin for two consecutive days, or * placebo for two consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Single-arm open-label study in healthy volunteers | Experimental | Drug: FisetinHealthy volunteers will receive fisetin. |
| RCT - Treatment group | Experimental | Drug: FisetinOlder patients with multimorbidity will receive fisetin. |
| RCT - Placebo group | Placebo comparator | Drug: PlaceboOlder patients with multimorbidity will receive placebo. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 20-35 years
- suPAR levels <3.5 ng/mL (± 15% corresponding to assay variation)
- Able to cooperate cognitively
- Able to read and understand Danish
- Women of childbearing potential must use effective contraception
Key exclusion criteria (39 listed)
- Body weight >100 kg
- Inability to swallow pills
- Pregnant and/or lactating
- Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules
- Presence of any condition that the investigator believes would put the subject at risk or would preclude the participant from successfully completing all aspects of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FisetinSubjects will receive fisetin corresponding to 20 mg/kg/day for two consecutive days. | Drug | RCT - Treatment group, Single-arm open-label study in healthy volunteers |
| PlaceboSubjects will receive a corresponding number of placebo capsules for two consecutive days. | Drug | RCT - Placebo group |
Primary outcome
Population-based pharmacokinetic model for fisetin and metabolites
Time frame: 24 hours
To develop a population-based pharmacokinetic (popPK) model for fisetin and its main metabolites in healthy volunteers and older patients, covariates such as body weight, body composition, age, and CYP inducers/inhibitors will be tested for influence on interindividual variability.
Adverse events
Time frame: Day 1 to 3
Number of participants to experience adverse events
suPAR
Time frame: Day 1 to 29
The change in plasma levels of suPAR and a sample size calculation based on these data.
15 secondary outcomes
Population-based PKPD model for fisetin
Time frame: 24 hours
Renal excretion of fisetin and its main metabolites
Time frame: 24 hours
Symptoms and adverse events
Time frame: Day 1 to 3
SASP factors and inflammation markers
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Senescence
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 8, 15, 29, 84.
Senolysis
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 84.
Aging markers
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Clinical markers
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Frailty Index OutRef
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Frailty Index
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Physical function
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Cognitive function (Montreal Cogntive Assessment)
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Cognitive function (Digit Symbol Substitution Test)
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Quality of life
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Self-rated health
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Only aggregated data can be available for other researchers due to Danish Data Protection Law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juliette Tavenier study chair
Copenhagen University Hospital, Amager and Hvidovre
Line Jee Hartmann Rasmussen study chair
Copenhagen University Hospital, Amager and Hvidovre
Morten B Houlind study chair
Copenhagen University Hospital, Amager and Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fisetin in people with Multimorbidity and Healthy, run by Ove Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliette Tavenier (+4538620640, juliette.tavenier@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population-based pharmacokinetic model for fisetin and metabolites (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.