Pharmacology Space Kit (PSK) - Dried Blood Spot for Caffeine Pharmacokinetics Under Microgravity Conditions

NCT06431984 | Completed

• 2 other identifiers: C22-802022-A02794-39
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Mechanism; Metabolism Medication Toxicity; Space Motion Sickness

Outcome Measures

Primary Outcomes (1)

• Percentage of valid capillary blood deposit on dry support

  A blood transfer is considered as successful IF the 3 following criteria are fulfilled 1. Blood spot covering \> 8 mm2 (3 mm punch circle) 2. Obtaining a drop of blood within the allotted time of 22 sec of microgravity 3. The drop is neither smeared nor smashed on the blotting paper

  through study completion, an average of 3 days

Secondary Outcomes (6)

• Identification of factors leading to self-sampling failure a. Time too short b. Insufficient drop c. Inadequate transfer

  through study completion, an average of 1 year

• Caffeine kinetic under different formulations and dosages

  through study completion, an average of 3 days

• Caffeine kinetic under different CYP1A2 genotypes

  through study completion, an average of 3 days

• Caffeine kinetic under different gravity conditions

  through study completion, an average of 3 days

• Acceptability

  through study completion, an average of 1 year

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Participants are healthy volunteers selected by the investigating team. The size of the study is limited by the number of individuals authorised to board the aircraft. The flying participants in the experiment will be the aircraft crew, i.e. volunteers from the research teams taking part in the parabolic flight. Healthy volunteers over the age of majority will be included in the study.

Diagnostic Test: prick test

Interventions

prick test DIAGNOSTIC_TEST

self-sampling of capillary blood using the finger prick test method

Healthy subjects

Eligibility Criteria

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

You may qualify if:

• Be affiliated to a social security scheme or benefit from such a scheme.
• Have obtained a medical certificate stating that they are fit for parabolic flights.
• Be aged between 18 and 70
• Be in good health: no chronic treatment that could interact with the metabolism of caffeine, no progressive disease
• Must not have any contraindications to taking caffeine (30 to 100 mg). Volunteers will also be asked not to consume caffeine (coffee, chocolate, energy drinks, tea, cola, etc.) in the 24 hours preceding the experiment.

You may not qualify if:

• Be the subject of a legal protection measure (safeguard of justice, curatorship or guardianship)
• suffer from haematophobia (irrational fear of blood)
• Have a current infectious disease, particularly viral
• Have an active chronic illness
• Have a high usual intake of caffeine (\>4 espressos, \>4 cups of tea, \>100g dark chocolate per day)
• Total intolerance to all forms of caffeine
• Smoke more than 20 cigarettes a day
• Have weaned themselves off smoking for less than a month
• Have a history of severe Raynaud's phenomenon
• Have a history of naupathy
• Suffering from naupathy during a flight

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

AIRBUS A 310 - Zero-G

Mérignac, 33700, France

Location

Related Publications (1)

• Derobertmasure A, Toh LS, Verstuyft C, Lukic S, De Sousa Carvalho C, Couronne R, Beauvalet M, Chhun S, Boutouyrie P. Feasibility of dried blood spot collection for caffeine pharmacokinetic studies in microgravity: Insights from parabolic flight campaigns. Br J Clin Pharmacol. 2026 Jan;92(1):35-47. doi: 10.1111/bcp.16320. Epub 2024 Oct 29.

  PMID: 39473131 BACKGROUND

MeSH Terms

Conditions

Space Motion Sickness

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Motion Sickness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 29, 2024
• Study Start: March 27, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: September 2, 2025

Record last verified: 2024-05

Locations

FR (1)