Healthy SubjectsNCT06017219
Bioavailability of Spermidine in Healthy Males
A study testing spermidine in people with Healthy Subjects, run by Chrysea Labs Lda at 1 site in Ireland.
Trial summary
To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse Events/Serious adverse events. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- spermidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIreland
- Study dates
- 5 May 2023to 14 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork
Cork
About this study
To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse Events/Serious adverse events.
Read the 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).
- Conditions
- Healthy Subjects
- Being tested
- spermidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spermidineDietary supplement
spermidine
| Study group | Role | What they receive |
|---|---|---|
| within subject control 20mg | Experimental | spermidine Receives: Dietary Supplement: spermidine |
| within subject control 40mg | Experimental | spermidine Receives: Dietary Supplement: spermidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
Maximum concentration of circulating spermidine (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pre dosing to dosing plus six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start5 May 2023
- Primary completion15 Oct 2023
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single blind cross over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chrysea Labs Lda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Patrick Keohane, Study director, Chrysea Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017219
- Sponsor's protocol ID
- AFCRO 167
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12702048
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Spermidine in Healthy Males
- ClinicalTrials.gov ID
- NCT06017219
- Acronym / sponsor ID
- AFCRO 167
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Chrysea Labs LdaIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single blind cross over study
| Arm | Type | Receives |
|---|---|---|
| within subject control 20mg | Experimental | Dietary Supplement: spermidinespermidine |
| within subject control 40mg | Experimental | Dietary Supplement: spermidinespermidine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spermidinespermidine | Dietary supplement | within subject control 20mg, within subject control 40mg |
Primary outcome
Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
Time frame: Pre dosing to dosing plus six hours
Maximum concentration of circulating spermidine (Cmax)
Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
Time frame: Pre dosing to dosing plus six hours
Time to peak of circulating spermidine (Tmax)
T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.
Time frame: Pre dosing to dosing plus six hours
Half-life of circulating spermidine (t1/2)
AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
Time frame: Pre dosing to dosing plus six hours
Area Under the Curve (AUC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 12702048Uda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Patrick Keohane study director
Chrysea Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spermidine in people with Healthy Subjects, run by Chrysea Labs Lda at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males (time frame: Pre dosing to dosing plus six hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06017219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.