Clinical trial NCT06017219: Bioavailability of Spermidine in Healthy Males
Official title: Bioavailability of Spermidine in Healthy Males
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Chrysea Labs Lda
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single blind cross over study
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse Events/Serious 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, T1/2, AUC).

Eligibility criteria: Inclusion Criteria:

* Able to give written informed consent.
* Male.
* Age between 18-70 years inclusive.
* BMI between ≥18.5 and ≤28 kg/m2.
* In general good health, as determined by the investigator.
* Agree to abstain from consuming alcohol, grapefruit, or grapefruit juice for 72 hours prior to visit 2 and visit 3.
* Adequate vein access for cannulation and multiple blood draws.
* Able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
* Willing to consume the study product.

Exclusion Criteria:

* History of anaphylaxis,
* Documented hypersensitivity reaction or a clinically important reaction to any dietary/food supplement or drug,
* Intolerance or sensitivity to study product ingredients

Primary outcomes:
measure: Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
timeFrame: Pre dosing to dosing plus six hours
measure: Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
timeFrame: Pre dosing to dosing plus six hours
measure: T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.
timeFrame: Pre dosing to dosing plus six hours
measure: AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
timeFrame: Pre dosing to dosing plus six hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork
Study officials:
affiliation: Chrysea Labs
name: Dr Patrick Keohane
role: STUDY_DIRECTOR
References:
citation: Uda K, Tsujikawa T, Fujiyama Y, Bamba T. Rapid absorption of luminal polyamines in a rat small intestine ex vivo model. J Gastroenterol Hepatol. 2003 May;18(5):554-9. doi: 10.1046/j.1440-1746.2003.03020.x.