Drug-Drug Interaction Between THC and AEF0117

NCT06395688 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: AEF0117-107U01DA053832
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cannabis Abuse

Keywords

Cannabis use disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Day1, Day8

Secondary Outcomes (12)

• AUC for co-administration of THC and AEF0117

  Day1, Day8

• Tmax for co-administration of THC and AEF0117

  Day1, Day8

• Tlag for co-administration of THC and AEF0117

  Day1, Day8

• Clast for co-administration of THC and AEF0117

  Day1, Day8

• t1/2 for co-administration of THC and AEF0117

  Day1, Day8

Study Arms (2)

AEF0117

EXPERIMENTAL

Participant will be administered once daily 2 placebo capsules for 1 day and 2 AEF0117 capsules for 7days

Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participant will be administered once daily 2 placebo capsules for 8 days.

Drug: Placebo

Interventions

3ß-(4-methoxybenzyloxy)pregn-5-en-20-one DRUG

AEF0117 soft capsules of 1mg

Also known as: AEF0117

AEF0117

Placebo DRUG

Placebo soft capsules (identical to active compound)

AEF0117; Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females of any race, 21 to 55 years old, both inclusive.
• Subjects must use highly effective contraception.
• Participants who engage in heterosexual sex must use highly effective contraception during the entire trial period. Male participants should refrain from donating sperm or planning a pregnancy throughout the trial. Female participants who are heterosexually active are eligible if: they use highly effective contraception or are post-menopausal and with a negative pregnancy test. Use of hormonal contraception must have been stable for 3 months prior to screening and expected to be unchanged during the trial.
• 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.

You may not qualify if:

• 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.
• b) The alcohol breath test and urine drug screen at predose Day 1 must be negative (including for cannabis, a level of THC-COOH \<100 ng/mL is allowed).
• 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.
• A corrected QT interval (Fridericia's correction, QTcF) \>450 msec for males and \>470 msec for females.
• Clinically significant anemia or low hemoglobin (levels \<9 g/dL) at screening, donation of \>250 mL of blood or plasma or received any blood and plasma for medical/surgical reasons within the 30 days prior to receiving trial drug, or intention to donate blood or plasma within 1 month after receiving trial drug.
• Allergies to the trial drug and known allergies to corn or corn derivatives.
• Use of any prescription or over-the-counter drug therapy, including psychoactive and/or psychotropic medication, herbal or homeopathic supplements unapproved by the sponsor within 2 weeks prior to receiving the trial drug (for drugs with an elimination half-life greater than 10 days, this will be extended to 60 days).
• Use of bodybuilding supplements, any food supplement or topical product containing pregnenolone, or any other steroid, including phytosteroids.
• Use of a diet or supplements (e.g., St. John's Wort), or food and fruit juices (e.g., grapefruit juice, Sevilla oranges) known to induce or inhibit hepatic drug metabolism within 2 weeks prior to receiving the trial drug and until the follow-up visit, unless approved by the sponsor's medical monitor.

Sponsors & Collaborators

• Aelis Farma: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Margaret Haney, PhD

  New York Institute Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind, placebo-controlled

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share