Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults (NCT03675724) | Clinical Trial Compass
By InvitationPhase 2
Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults
United States40 participantsStarted 2018-11-15
Plain-language summary
This is a pilot study to test the efficacy of the anti-inflammatory drug (Fisetin) in reducing inflammatory factors in blood in elderly adults and to test the efficacy of the drug (Fisetin) in reducing frailty and markers of inflammation, insulin resistance, and bone resorption in elderly adults.
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria
• Age ≥ 70 years
Exclusion Criteria
* Unable or unwilling to give informed consent
* Pregnant
* Body weight \>150 kg or body mass index (BMI) \> 50
* QTc\>450 msec
* Total bilirubin \>2X upper limit of normal
* Inability to tolerate oral medication
* Abnormality in any of the screening laboratory studies (see below)
* Human immunodeficiency virus infection
* Known active hepatitis B or C infection
* Invasive fungal or viral infection
* Known hypersensitivity or allergy to fisetin
* Uncontrolled pleural/pericardial effusions or ascites
* New/active invasive cancer except non-melanoma skin cancers
* Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.
* Strong inhibitors of CYP3A4. See Appendices 1-3.
* Tyrosine kinase inhibitor therapy
* Known hypersensitivity or allergy to fisetin
* Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days.
* Subjects taking H2-antagonists and unwilling to discontinue therapy for 1 week before and 2 weeks following enrollment.
* Subjects taking potentially senolytic agents within the last year: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoc…