Drug-Drug Interaction Between THC and AEF0117 (NCT06395688) | Clinical Trial Compass
WithdrawnPhase 1
Drug-Drug Interaction Between THC and AEF0117
Stopped: Due to several issues, this study has never been submitted to the IRB. So the sponsor was decided to withdraw it.
0Started 2025-12
Plain-language 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.
Who can participate
Age range21 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy males and females of any race, 21 to 55 years old, both inclusive.
✓. Subjects must use highly effective contraception.
✓. Body mass index (BMI) between 20.0 and ≤35.0 kg/m2 at screening.
✓. Be informed of the nature of the trial and provide written informed consent.
✓. Be legally competent and able to communicate effectively (in English) with trial personnel.
✓. Cannabis smoker (use ≥1 day the last 2 months and ≤2 days/week) who agrees to abstain from cannabis (except for what is provided by investigators) for 3 days prior to and including Day 1 and Day 8 of the study, and while in the clinic.
Exclusion criteria
✕. Severe learning disability, brain damage, or pervasive developmental disorder.
✕. Any disease or condition that according to the investigator's medical judgment might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
✕. Any clinical laboratory values assessed as clinically significant by the investigator.
✕. a) A history of alcohol- or substance use disorders within the past 2 years, recent or current regular use of any illicit drugs except cannabis. In case of a positive drug screen (except for cannabis) at screening, a negative test is required at re-screening.
. A history of or current serious mental illness including active or recent suicidal ideation, severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder), and/or an abnormal Columbia-Suicide Severity Rating Scale (C-SSRS) result (i.e., a C-SSRS score of ≥3).
✕. History of COVID-19 within 4 weeks prior to Day 1, or positive COVID 19 test if required according to standard procedures at the site.
✕. A history of difficulty donating blood or inadequate venous access.
✕. Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant by the investigator.