This trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence. The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis. Participants will be male or female in good health aged from 21y to 55y old and who are recreational cannabis users. The participant will receive either AEF0117 (2 mg) or placebo. The sponsor team, the research staff and the participant won't know which study medication has been given. The main objectives of the trial are: * To compare the effect of AEF0117 multiple doses on the maximal plasma concentration and other pharmacokinetic parameters of the THC and its metabolites. * To investigate safety and tolerability of multiple doses of AEF0117 and when co-administered with a dose of smoked cannabis. The participant will come for 2 inpatient phases (including one overnight stay). Those 2 inpatient phases are separated by 5 days at home. After a screening period assessing the good health and the eligibility of the participant, on day 1 they will receive 2 capsules of the study medication and will smoke one cannabis cigarette. During the day, blood samples will be collected at defined timepoints before the study medication, after the study medication and before smoking and after smoking. On day 2, Blood samples will be collected before and after the study medication intake. At the end of the assessements, the participant will be discharged. They could be requested to stay at the research facility if they experience any adverse effects From Day 3 to Day 7, the participant will be contacted by phone or by videoconference to confirm the study medication intake and if they experience any adverse events. On day 8, the participant will come back to the research facility for a 2 days visit including an overnight stay. Assessments and procedures will similar to those performed on Day 1 and Day 2. On Day 14, the participant will come back to the research facility a last time for a final blood collection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
AEF0117 soft capsules of 1mg
Placebo soft capsules (identical to active compound)
Cmax for co-administration of THC and AEF0117
Comparison of the maximal plasma concentration (Cmax) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo.
Time frame: Day1, Day8
AUC for co-administration of THC and AEF0117
Comparison of the area under the curve (AUC) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo.
Time frame: Day1, Day8
Tmax for co-administration of THC and AEF0117
Comparison of time of peak concentration of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
Tlag for co-administration of THC and AEF0117
Comparison of Tlag of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
Clast for co-administration of THC and AEF0117
Comparison of Clast of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
t1/2 for co-administration of THC and AEF0117
Comparison of plasma half-life (t1/2) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
Cmax for 11-OH-THC and THC-COOH
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Comparison of peak concentration (Cmax) of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
AUC for 11-OH-THC and THC-COOH
Comparison of the area under the curve (AUC) of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
Tmax for 11-OH-THC and THC-COOH
Comparison of the time of peak concentration (Tmax) of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
Tlag for 11-OH-THC and THC-COOH
Comparison of Tlag of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8
Incidence of TEAEs or TESAEs
Assessed by AE and SAE reporting
Time frame: From Day1 to Day14
Incidence of TEAEs and TESAEs assessed by vital signs
By evaluating changes from the baseline in vital signs
Time frame: Day1, Day2, Day8, Day9, Day14
Effect on heart rate
Measurement of Heart rate over predefined time intervals from prior to IMP dosing until 11 hours after dosing during co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Time frame: Day1, Day8