Phase 1/2Recruiting
Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity (Fisetin HIGH)
Pharmacokinetics, Safety, and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study
- Sponsor
- Ove Andersen (Academic or other)
- Enrolment
- 60 planned
- Conditions
- Multimorbidity; Healthy
- Interventions
- Fisetin; Placebo
- Ages
- adults, older adults
- Registry
- NCT06431932
From the registry
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.
Primary outcomes
- Population-based pharmacokinetic model for fisetin and metabolites
- Adverse events
- suPAR