Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431984
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-15
Brief Title:
Pharmacology Space Kit PSK - Dried Blood Spot for Caffeine Pharmacokinetics Under Microgravity Conditions
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Kit de Pharmacologie Spatial - Analyse de lUtilisation Des Dried Blood Spot Pour le Dosage de la caféine Chez Des Volontaires Sains en microgravité au Cours Des Vols Paraboliques
Status:
COMPLETED
Status Verified Date:
2024-05
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:
PSK
Brief Summary:
The PSK study is preliminary to the study of drug metabolism in space flight conditions The investigators propose to use simplified blood sampling methods that can be applied in microgravity This method is based on the use of capillary blood obtained using an automatic lancet for diabetics the blood droplet then being deposited on specific blotting paper and then studied in the laboratory In 2022 the investigators validated the transfer of artificial blood in parabolic flight conditions as well as the validity of cardiovascular drug dosage
The objective of the 2023 study is to validate the collection and transfer of capillary blood on themselves by healthy volunteers with little training for the blood dosage of caffeine after intake of standard doses of alimentary caffeine
The primary objective is a feasibility of 90 of sampling in microgravity compared with 95 on ground Secondary objectives are the pharmacokinetic of different forms of caffeine according to genetic background and other modifiers of CYP1A2
The objective of the 2023 study is to validate the collection and transfer of capillary blood on themselves by healthy volunteers with little training for the blood dosage of caffeine after intake of standard doses of alimentary caffeine
The primary objective is a feasibility of 90 of sampling in microgravity compared with 95 on ground Secondary objectives are the pharmacokinetic of different forms of caffeine according to genetic background and other modifiers of CYP1A2
Detailed Description:
The investigators propose to use simplified blood sampling methods that can be applied in microgravity This method is based on the use of capillary blood obtained using an automatic lancet for diabetics the blood droplet then being deposited on specific blotting paper and then studied in the laboratory
The objective of the study is to validate the collection and transfer of capillary blood from finger prick test performed on themselves by healthy volunteers after a short training for the blood dosage of caffeine Dietary caffeine will be used issued from standardized espresso tea or dark chocolate
Caffeine is a universally used food substance and is metabolised by a pathway common to many drugs CYP 1A2 The aim is to show that it is possible to collect blood in this way and to carry out assays of caffeine Secondary objectives are to assess the kinetics of caffeine metabolism through the metabolic ratio AUC paraxanthineAUC caffeine and to correlate these kinetics with genetic variations in CYP 1A2 activity
Participants are healthy volunteers already selected to take part in the parabolic flight campaign
A success rate of 95 for ground sampling and 90 for in-flight sampling is assumed as satisfactory If 5 volunteer participants during the 3 days of flying carry out 2 in-flight samplings this results in 30 in-flight samplings If the other 25 flying volunteers take only one in-flight sample means 25 in-flight samples total 55 On the ground the 30 volunteers will take 90 samples for a total of 145 minimum samples An equivalence threshold for a maximum 20 difference between flight and ground conditions is considered For a difference of 10 15 and 20 the power is 34 79 and 97 respectively It can therefore conclude that the difference between the two sampling conditions is not clinically significant
The objective of the study is to validate the collection and transfer of capillary blood from finger prick test performed on themselves by healthy volunteers after a short training for the blood dosage of caffeine Dietary caffeine will be used issued from standardized espresso tea or dark chocolate
Caffeine is a universally used food substance and is metabolised by a pathway common to many drugs CYP 1A2 The aim is to show that it is possible to collect blood in this way and to carry out assays of caffeine Secondary objectives are to assess the kinetics of caffeine metabolism through the metabolic ratio AUC paraxanthineAUC caffeine and to correlate these kinetics with genetic variations in CYP 1A2 activity
Participants are healthy volunteers already selected to take part in the parabolic flight campaign
A success rate of 95 for ground sampling and 90 for in-flight sampling is assumed as satisfactory If 5 volunteer participants during the 3 days of flying carry out 2 in-flight samplings this results in 30 in-flight samplings If the other 25 flying volunteers take only one in-flight sample means 25 in-flight samples total 55 On the ground the 30 volunteers will take 90 samples for a total of 145 minimum samples An equivalence threshold for a maximum 20 difference between flight and ground conditions is considered For a difference of 10 15 and 20 the power is 34 79 and 97 respectively It can therefore conclude that the difference between the two sampling conditions is not clinically significant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A02794-39 | REGISTRY | IDRCB | None |