Bioavailability of Spermidine in Healthy Males

Status Active, not recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Healthy Subjects

Clinical Trial Details

NCT number	NCT06017219
Study type	Interventional
Source	Chrysea Labs Lda
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 5, 2023
Completion date	March 14, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05483998` - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants	Phase 1
Recruiting	`NCT02235012` - Cognitive Biases Under Ketamine	N/A
Recruiting	`NCT02417714` - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed	`NCT04418973` - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.	N/A
Completed	`NCT05088343` - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06248801` - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets	Phase 1
Terminated	`NCT04068259` - Single Ascending Dose Study of PBI-4547 in Healthy Subjects	Phase 1
Completed	`NCT03279302` - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06233162` - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets	Phase 1
Recruiting	`NCT04159844` - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects	N/A
Completed	`NCT06137911` - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.	Phase 1
Completed	`NCT04849286` - Measurement of HTL0016878 in Cerebrospinal Fluid	Phase 1
Not yet recruiting	`NCT06233227` - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule	Phase 1
Completed	`NCT04096157` - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants	Phase 1
Completed	`NCT01200368` - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants	Phase 3
Recruiting	`NCT05805033` - Peri-Implant Soft Tissue Integration in Humans: Influence of Material	N/A
Completed	`NCT04027803` - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®	Phase 1
Recruiting	`NCT03467880` - Multicenter Study of Impulse Oscillometry in Chinese	N/A
Completed	`NCT02903095` - Single Ascending Dose Study of TD-1439 in Healthy Subjects	Phase 1
Active, not recruiting	`NCT02341508` - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers	Phase 1