Health TrialsbyHealthPanel

Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity

ConditionsMultimorbidityHealthy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorOve Andersen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Body weight >100 kg

Inability to swallow pills

Pregnant and/or lactating

Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fisetin

    Drug

    Subjects will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.

  • Placebo

    Drug

    Subjects will receive a corresponding number of placebo capsules for two consecutive days.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Single-arm open-label study in healthy volunteersExperimental treatment 1 intervention
Group B: RCT - Treatment groupExperimental treatment 1 intervention
Group C: RCT - Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours
2

Adverse events

Number of participants to experience adverse events

Time frame
Day 1 to 3
3

suPAR

The change in plasma levels of suPAR and a sample size calculation based on these data.

Time frame
Day 1 to 29

Secondary outcomes

1

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.

Time frame
24 hours
2

Renal excretion of fisetin and its main metabolites

Urinary levels of fisetin and its main metabolites

Time frame
24 hours
3

Symptoms and adverse events

Number of participants to experience symptoms and clinically significant changes in vital signs (i.e., blood pressure, pulse).

Time frame
Day 1 to 3
4

SASP factors and inflammation markers

The change in plasma levels of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors).

Time frame
Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ove Andersen

Lead sponsor

Hvidovre University Hospital

Sponsor institution

University of Southern Denmark

Collaborator

Mayo Clinic

Collaborator

Source ClinicalTrials.gov
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