AIRBUS A 310 - Zero-G
Mérignac, 33700, France
NCT Number: NCT06431984
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Mérignac, 33700, France
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 paraxanthine/AUC 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
self-sampling of capillary blood using the finger prick test method
Time frame: through study completion, an average of 3 days
A blood transfer is considered as successful IF the 3 following criteria are fulfilled
Time frame: through study completion, an average of 1 year
Identification of self-sampling failure factors
Time frame: through study completion, an average of 3 days
Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine)
Time frame: through study completion, an average of 3 days
Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine)
Time frame: through study completion, an average of 3 days
Area under the curve of caffeine and paraxanthine, metabolic ratio (para/caffeine)
Time frame: through study completion, an average of 1 year
A paper questionnaire will be handed out just after the parabolic flight at the time of the last sampling. It will be made up of closed questions based on 3 dimensions of satisfaction:
Time frame: through study completion, an average of 1 year
Area under the curve of caffeine and paraxanthin, metabolic ratio (para/caffeine) at 6 months interval
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Kit de Pharmacologie Spatial - Analyse de l'Utilisation Des Dried Blood Spot Pour le Dosage de la caféine Chez Des Volontaires Sains en microgravité au Cours Des Vols Paraboliques
Acronym: PSK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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