Fisetin dosing equivalence study

Principal Clinical Investigator: Dustin Anderson, MD

This is a prospective randomized controlled trial evaluating if the supplement Fisetin, safely reduces senescent cells, and if so, to compare this reduction when taking a daily dose (once a day) versus a bolus dose (single dose given over a short period of time-2 days). This clinical trial will be conducted at The Steadman Clinic and Steadman Philippon Research Institute. 

Primary Objectives:

• Determine if daily and bolus doses of Fisetin reduce serum biomarkers of Senescence-Associated Secretory Phenotype (SASP).
• To define the safety and tolerability of Fisetin administered as a bolus and daily regimen.
• To evaluate changes in senescence biomarker values within bolus dosing windows when compared to a daily dosing regimen.

Eligibility Criteria:

Inclusion Criteria:
Subjects will be included if all the following criteria are met:

1. Are male or females 55 years of age and older
2. Are willing to comply with all study related procedures and assessments

Exclusion Criteria:
Subjects will be excluded if any of the following criteria are met:

1. Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing;
2. Males who do not wish to abstain from sex or use contraceptive protection;
3. Subjects who do not have the capacity to consent themselves;
4. Subjects who are unable to tolerate oral medication;
5. Subjects with any of the following drug/medication statuses:
   • Currently taking Warfarin or related anticoagulants;
   • Currently taking lithium
   • Taking a glucocorticoid within 1 month of signing informed consent;
   • Senolytic agents taken within the past 6 months and are not willing to discontinue these medications through the duration of the study, including: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax;
   • Drugs that induce significant cellular stress and are not willing to discontinue these medications through the duration of the study, including alkylating agents, anthracyclines, platins, other chemotherapy drugs; 
   • Subjects taking the following other drugs if they cannot be held (per the Principal Investigator) for at least 2 days before and during administration of Fisetin: Cyclosporine, tacrolimus, repaglinide, and bosentan.
6. Subjects with any of the following disease statuses:
   • Significant liver disease (i.e. greater than or equal to 2x the upper limit of normal bilirubin levels) or as in the opinion of the Principal Investigator;
   • Significant renal disease (eGFR of <60 ml/min/1.73m2) or as in the opinion of the Principal Investigator;
7. Subjects that have any medical condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation or prevent the patient from fully participating in all aspects of the study.
8. Subjects with Patient Health Questionnaire (PFQ-9) total score exceeds 9

If you would like more information about the study, please contact us at clinicaltrials@sprivail.org or 970-409-7566.