Safety profile Pharmacokinetics Healty volunteers Veiligheidsprofiel Farmacokinetiek Healthy volunteers
Conditions
Interventions
Participants will receive a single dose of 100 and 150 mg of 4-FA on separate days.
Sponsors
Maastricht University
Eligibility
Inclusion criteria
Inclusion criteria: Previous experience with psychostimulants (≤ 1 time / week) and at least one time during the previous year • Age between 18 and 40 years • Free from psychotropic medication • The participant is in good health, in the opinion of the investigator, based on assessments of medical history, physical examinations, vital signs, electrocardiogram, and the results of haematology, clinical chemistry, urinalysis, serology, and other laboratory tests • Clinical laboratory test values within the reference ranges. Borderline values may be accepted if they are, in the opinion of the investigator, clinically insignificant. • Absence of any major medical, endocrine and neurological condition, as determined by the medical history, medical examination, electrocardiogram and laboratory analyses (haematology, clinical chemistry, urinalysis, serology) • Normal binocular visual acuity, corrected or uncorrected • Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2 • Written Informed Consent
Exclusion criteria
Exclusion criteria: History of drug abuse or addiction (determined by the medical questionnaire, drug questionnaire and medical examination) • Excessive drinking (> 20 alcoholic consumptions a week) • Pregnancy or lactation • Hypertension (diastolic> 90; systolic> 140) • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) • Liver dysfunction • (Serious) side effects to previous psychostimulant use • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…) • Simultaneous participation in another clinical trial • For women: not using reliable contraceptive • Blood donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety profile, vital signs (body temperature, blood pressure, heart rate and respiratory rate), clinical laboratory safety (hematology, clinical chemistry and urinalysis) and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics, cognitive performance (cognitive tests), mood and subjective drug experience (questionnaires) | — |
Contacts
Public ContactE.B. Sousa Fernandes Perna
Maastricht University | Faculty of Psychology and Neuroscience | Department of Neuropsychology and Psychopharmacology
Outcome results
None listed