NCT06395688

Drug-Drug Interaction Between THC and AEF0117

A Double Blind, Placebo-controlled Trial in Healthy Volunteers to Investigate the Effect of Multiple Oral Doses of AEF0117 Versus Placebo on the Pharmacokinetics of THC and Its Metabolites 11 OH THC and THC COOH When Smoking Cannabis.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aelis Farma · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cannabis Abuse

Interventions

Type	Name	Description
DRUG	3ß-(4-methoxybenzyloxy)pregn-5-en-20-one	AEF0117 soft capsules of 1mg
DRUG	Placebo	Placebo soft capsules (identical to active compound)

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-05-02
• Last updated: 2026-02-27

Regulatory

• FDA-regulated drug study