A Phase 1 interventional study of 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition and 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition in Marijuana Abuse, sponsored by Aelis Farma. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Aelis Farma · Phase 1, Interventional, and Other
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders.
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.
Cannabis is the most widely used illicit drug with approximately 28 million individuals reporting past-month use, and 14% of those receiving substance use disorder treatment in the US reporting cannabis as their primary drug of abuse. While psychotherapeutic approaches have some utility for treating Cannabis Use Disorder (CUD), the vast majority of patients have difficulty significantly reducing their use or achieving abstinence. Safe and effective medications to treat CUD are urgently needed. The overall goal of this clinical trial is to contribute to advancing a safe and effective pharmacotherapy for CUD along the FDA approval pipeline.
When the CB1 receptors are over-activated by very high doses of THC, quite higher than the doses of THC used by cannabis abusers, the concentration of the steroid hormone pregnenolone increases in the brain. Pregnenolone then binds to a specific site on the CB1 receptors, distinct for the one of CB1 agonists and THC, and acts as an endogenous signaling specific inhibitor of the CB1 receptors. Pregnenolone cannot be used as a pharmacological treatment because it is poorly bioavailable, has a very short half-life and is converted downstream to active steroids. Aelis Farma, in collaboration with researchers from the Institut National de la Santé et de la Recherche Médicale (INSERM), has developed a new pharmacological class, the synthetic signaling specific inhibitor of the CB1 receptor (sCB1-SSi) AEF0117, by modifying pregnenolone's chemical structure to prevent conversion to active steroids, and to increase absorption and biological stability while maintaining THC antagonism.
To date, 3 clinical studies have been completed with AEF0117 including 2 phase 1 studies in healthy volunteers (AEF0117-101 single ascending dose study and AEF0117 102, multiple ascending dose study), and a phase 2a trial in cannabis users (AEF0117 201). The phase 1 studies showed good safety and tolerability of AEF0117 in the dose range tested (0.2 mg as single dose and 0.6-6 mg/day as single and multiple doses) and the phase 2a trial found that the 1 mg/day dose of AEF0117 significantly reduced both the abuse-related subjective effects of cannabis and its self-administration, while the 0.06 mg dose did not. Importantly, AEF0117 was well tolerated in daily cannabis smokers, with no evidence of precipitated withdrawal, physical, or psychological discomfort. There were no SAEs and a limited number of TEAEs. These results confirm preclinical data showing that AEF0117 does not function as an orthosteric antagonist and does not produce any of the adverse effects associated with rimonabant. Thus, AEF0117 is to our knowledge the first medication to safely and robustly attenuate the positive subjective and reinforcing effects of cannabis in participants with CUD.
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.
188 studies on the registry are indexed under Marijuana Abuse; 26 are open to participants now.
This study's enrollment of 22 is below the median of 51 across 160 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →Aelis Farma is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
16 participants receive 1 dose of AEF0117 1 mg in fasted condition
Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition
16 participants receive 1 dose of AEF0117 1 mg fed condition
Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition
a single dose of 1 mg AEF0117 in fed condition
Also known as: AEF0117
a single dose of 1 mg AEF0117 in fasting condition
Also known as: AEF0117
Cmax of AEF0117
Plasma concentration maximum(Cmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Time frame: up to 312 hours after dosing
Tmax of AEF0117
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Time frame: up to 312 hours after dosing
AUC (Area Under Curve) t to Last Concentration of AEF0117
Area under the plasma concentration (AUC to Last Nonzero Conc) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Time frame: up to 312 hours after dosing
AUC (Area Under Curve) t to Infinity Observed of AEF0117
Area under the plasma concentration (AUC infinity obs) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Time frame: up to 312 hours after dosing
Bioavailibility of AEF0117 (Tlag)
Tlag is the Time point of first quantifiable concentration after dose administration
Time frame: up to 312 hours after dosing
Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure
Lowest Peak Plasma (Cmin) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Time frame: up to 312 hours after dosing
Terminal Elimination Half-life (t1/2) of AEF0117
Terminal elimination half-life (t1/2) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Time frame: up to 312 hours after dosing
Incidence of Treatment-Emergent Adverse Event
Number of participant reporting at least one Adverse Event
Time frame: up to 312 hours after AEF0217 dosing
| Milestone | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition |
|---|---|---|
| Started | 11 | 11 |
| Completed | 11 | 7 |
| Not completed | 0 | 4 |
Plasma concentration maximum(Cmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
| pg/mL | AEF0117 1.0 mg Once Daily (QD) in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| Cmax of AEF0117 | 6.87 ± 38.0 | 3.76 ± 28.6 |
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
| hours | AEF0117 1.0 mg Once Daily (QD) in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| Tmax of AEF0117 | 3.5165 (2.0170 to 6.0000) | 3.0000 (2.0000 to 3.0000) |
Area under the plasma concentration (AUC to Last Nonzero Conc) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
| hours*pg/mL | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| AUC (Area Under Curve) t to Last Concentration of AEF0117 | 61.50 ± 22.0 | 34.43 ± 27.8 |
Lowest Peak Plasma (Cmin) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
| pg/mL | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure | 373.9108 ± 149.2681 | 154.1652 ± 62.7416 |
Terminal elimination half-life (t1/2) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
| hours | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| Terminal Elimination Half-life (t1/2) of AEF0117 | 170.5580 (32.5230 to 212.9730) | 212.3460 (181.7600 to 242.7210) |
Area under the plasma concentration (AUC infinity obs) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
| hours*pg/mL | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| AUC (Area Under Curve) t to Infinity Observed of AEF0117 | 70.86 ± 23.7 | 42.14 ± 26.0 |
Tlag is the Time point of first quantifiable concentration after dose administration
| hours | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| Bioavailibility of AEF0117 (Tlag) | 0.5000 (0.0000 to 1.0000) | 0.0000 (0.0000 to 0.0000) |
Number of participant reporting at least one Adverse Event
| Participants | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Event | 3 | 6 |
Collected over from D1 (IP administration) until D14. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AEF0117 1.0 mg in Fed Condition | 0/11 (0%) | 0/11 (0%) | 3/11 (27.3%) |
| AEF0117 1.0 mg in Fasted Condition | 0/11 (0%) | 0/11 (0%) | 6/11 (54.5%) |
| Event | AEF0117 1.0 mg in Fed Condition | AEF0117 1.0 mg in Fasted Condition |
|---|---|---|
| HeadacheNervous system disorders | 0/11 | 3/11 |
| Brain FogNervous system disorders | 0/11 | 1/11 |
| MalaiseGeneral disorders | 1/11 | 0/11 |
| DizzinessNervous system disorders | 0/11 | 1/11 |
| coordination abnormalNervous system disorders | 0/11 | 1/11 |
| PainGeneral disorders | 1/11 | 0/11 |
| Back painMusculoskeletal and connective tissue disorders | 1/11 | 0/11 |
| Age, Categorical(Participants) | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 22 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 9 | 9 | 18 |
| Race (NIH/OMB)(Participants) | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 11 | 8 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kg) | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition | Total |
|---|---|---|---|
| Mean | 85.45 ± 11.46 | 81.25 ± 13.65 | 83.35 ± 12.48 |
| Body Mass Index(kg/m2) | AEF0117 1.0 mg in Fasted Condition | AEF0117 1.0 mg in Fed Condition | Total |
|---|---|---|---|
| Mean | 27.195 ± 3.161 | 26.307 ± 3.145 | 26.751 ± 3.110 |
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Studies of the drug tested here: Lixosicone
Aelis Farma