A Comparison of Fisetin Kinetics in Young and Old Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

Fisetin - Fasted condition: A single oral dose of 500 mg fisetin (as Novusetin®) will be administered as 5 capsules with 240 ml of still water in the overnight fasting condition: A total of 24 blood samples will be taken at defined time points (baseline; 10; 20; 30; 40; 50; 60; 80; 100 min; 2.0; 2.5; 3.0; 3.5; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 9.0; 10.0 h). At each time point, blood will be collected (4.9 ml for separation of plasma) to determine fisetin, and fisetin metabolites. The total amount of blood collected for each participant and each arm is 164 ml at the kinetic visits and 12 ml at the screening visit. Urine will be collected during the first 10 hours after fisetin administration.

Fisetin - Fed condition: A single oral dose of 500 mg fisetin (as Novusetin®) will be administered as 5 capsules with 240 ml of still water in fed condition: Participants will eat a high-caloric and high-fat meal based on the recommendation of the FDA (Food and Drug Administration) for food-effect studies. This meal will contain two slices of toast with butter, two eggs fried in butter, approx. 113 g hash brown potatoes and 240 ml whole milk. A total of 24 blood samples will be taken at defined time points (baseline; 10; 20; 30; 40; 50; 60; 80; 100 min; 2.0; 2.5; 3.0; 3.5; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 9.0; 10.0 h). At each time point, blood will be collected (4.9 ml for separation of plasma) to determine fisetin, and fisetin metabolites. The total amount of blood collected for each participant and each arm is 164 ml at the kinetic visits and 12 ml at the screening visit. Urine will be collected during the first 10 hours after fisetin administration.

Study summary

This study investigates the differences in the kinetic parameters of fisetin in two cohorts of healthy volunteers:

Cohort 1) volunteers aged 18-30 years (n = 40) Cohort 2) volunteers aged 65 years or older (n = 40)

The purpose of this study is:

1. To describe the fisetin kinetics after a single dose oral administration in older age.
2. To compare the fisetin kinetics after a single dose oral administration in old and young age.

FISEKIN-1 is designed as a four-arm study protocol. As well as two different age groups (18-30 years vs. 65 years and older), we want to compare fisetin kinetic parameters in fasted and fed condition:

Arm 1) 500 mg fisetin (1x 5 capsule), fasted condition, cohort 1: young age Arm 2) 500 mg fisetin (1x 5 capsule), fasted condition, cohort 2: old age Arm 3) 500 mg fisetin (1x 5 capsule), fed condition, cohort 1: young age Arm 4) 500 mg fisetin (1x 5 capsule), fed condition, cohort 2: old age

Eligibility

Primary outcome measure(s)

• Fisetin plasma concentration arm 1 vs. arm 2 — 10 hours
  Difference of fisetin plasma concentrations between the young and old cohort, expressed as area under the curve (AUC0-10h).
• Fisetin plasma concentration arm 3 vs. arm 4 — 10 hours
  Difference of fisetin plasma concentrations between the young and old cohort, expressed as area under the curve (AUC0-10h).

Trial sites (1)

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