Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017219
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-08-14
Brief Title:
Bioavailability of Spermidine in Healthy Males
Sponsor:
Chrysea Labs Lda
Organization:
Chrysea Labs Lda
Study Overview
Official Title:
Bioavailability of Spermidine in Healthy Males
Status:
ACTIVE_NOT_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:
To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse EventsSerious adverse events
Detailed Description:
Until now lack of availability of a reproducible high quality uncontaminated spermidine for human consumption as a food or supplement has been a significant barrier to its study and use
Chrysea is producing spermidine by a patented biological process to consistently produce very high purity spermidine to pharmaceutical and food grade standards
Using a rat ex vivo jejunal absorption model and 14Carbon labelled spermidine the recovery rate of radioactivity at the portal vein was approximately 61-76 during the initial 10 minutes after the administration of 14C-spermidine
Data on spermidine absorption in humans is very limited The purpose of this single blind randomised pharmacokinetic study is to demonstrate absorption of 20mg and 40 mg doses of spermidine in fasted normal volunteers and to describe the absorption kinetics Tmax Cmax T12 AUC
Chrysea is producing spermidine by a patented biological process to consistently produce very high purity spermidine to pharmaceutical and food grade standards
Using a rat ex vivo jejunal absorption model and 14Carbon labelled spermidine the recovery rate of radioactivity at the portal vein was approximately 61-76 during the initial 10 minutes after the administration of 14C-spermidine
Data on spermidine absorption in humans is very limited The purpose of this single blind randomised pharmacokinetic study is to demonstrate absorption of 20mg and 40 mg doses of spermidine in fasted normal volunteers and to describe the absorption kinetics Tmax Cmax T12 AUC
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?:
None
Is an FDA AA801 Violation?:
None