Bioavailability of Spermidine in Healthy Males

NCT06017219 | Active Not Recruiting

• 1 other identifier: AFCRO 167
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males

  Maximum concentration of circulating spermidine (Cmax)

  Pre dosing to dosing plus six hours

• Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males

  Time to peak of circulating spermidine (Tmax)

  Pre dosing to dosing plus six hours

• T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.

  Half-life of circulating spermidine (t1/2)

  Pre dosing to dosing plus six hours

• AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males

  Area Under the Curve (AUC)

  Pre dosing to dosing plus six hours

Study Arms (2)

within subject control 20mg

EXPERIMENTAL

spermidine

Dietary Supplement: spermidine

within subject control 40mg

EXPERIMENTAL

spermidine

Dietary Supplement: spermidine

Interventions

spermidine DIETARY_SUPPLEMENT

spermidine

within subject control 20mg; within subject control 40mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chrysea Labs Lda: lead

Study Sites (1)

Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork

Cork, Ireland

Location

Related Publications (1)

• 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.

  PMID: 12702048 BACKGROUND

MeSH Terms

Interventions

Spermidine

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Study Officials

• Dr Patrick Keohane

  Chrysea Labs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single blind cross over study

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 30, 2023
• Study Start: May 5, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 14, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)