Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-15
Brief Title:
Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
Sponsor:
Ove Andersen
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Pharmacokinetics Safety and Efficacy of Fisetin - A Phase I and Pilot Phase IIa Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The goal of this pilot trial is to conduct a controlled clinical study to gather data on the pharmacokinetic profile of fisetin and its metabolites and on the safety and tolerability of fisetin in healthy volunteers as well as in older medical patients Furthermore we aim to identify potential outcome measures and perform sample size calculations for these outcomes with the intent to conduct a larger scale effect study at later date given the result from this pilot study suggests that this would be feasible and safe
The trial consists of
a single-arm open-label study in which healthy volunteers n20 will receive fisetin corresponding to 20 mgkgday for two consecutive days
a 2-arm triple-blind randomized placebo-controlled study in which older medical patients n40 will receive either
20 mgkgday fisetin for two consecutive days or
placebo for two consecutive days
Each of the studies open-label study and randomized placebo-controlled study consists of three sub-studies
Sub-study I aims to investigate the pharmacokinetic properties of fisetin and its main metabolites following oral administration at a dose of 20 mgkgday in healthy volunteers and in older medical patients
Sub-study II aims to assess the safety and tolerability of oral treatment with fisetin at a dose of 20 mgkgday fisetin for two consecutive days in healthy volunteers and in older medical patients
Sub-study III aims to gather representative measurements to assess the utility of inflammation SASP senescence senolysis and aging biomarkers as well as measures of frailty clinical parameters physical and cognitive function and quality of life as potential outcomes in future clinical trials additionally to perform sample size calculations for future trials based on these data
The trial consists of
a single-arm open-label study in which healthy volunteers n20 will receive fisetin corresponding to 20 mgkgday for two consecutive days
a 2-arm triple-blind randomized placebo-controlled study in which older medical patients n40 will receive either
20 mgkgday fisetin for two consecutive days or
placebo for two consecutive days
Each of the studies open-label study and randomized placebo-controlled study consists of three sub-studies
Sub-study I aims to investigate the pharmacokinetic properties of fisetin and its main metabolites following oral administration at a dose of 20 mgkgday in healthy volunteers and in older medical patients
Sub-study II aims to assess the safety and tolerability of oral treatment with fisetin at a dose of 20 mgkgday fisetin for two consecutive days in healthy volunteers and in older medical patients
Sub-study III aims to gather representative measurements to assess the utility of inflammation SASP senescence senolysis and aging biomarkers as well as measures of frailty clinical parameters physical and cognitive function and quality of life as potential outcomes in future clinical trials additionally to perform sample size calculations for future trials based on these data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506284-34-00 | CTIS | None | None |