ClinicalTrials.gg
TerminatedNCT05451017Updated Jan 22, 2026Results posted

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers

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

Why this study was terminated
Study was initially paused due to a research hold of the institution. However, the study will not continue as the sample size of patients collected prior to the pause allowed for adequate data analysis of the study endpoints.
Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Marijuana Abuse

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Keywords

  • AEF0117
  • Cannabis-related Use Disorder
  • Cannabis subjective effects
  • Cannabis self-administration cannabis-induced analgesia
  • Cannabis-related cognitive disorder
03

In context

Marijuana Abuse

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Healthy, non-smoking male or female of any race, 18 to 55 years old, both inclusive.
  2. Both males and female participants must use highly effective during the entire trial period. Male participants should refrain from donating sperm or planning a pregnancy throughout the trial. Male participants must agree to use double-barrier contraceptive methods: male condoms and spermicide. FHeterosexually active females are only eligible if they are documented to be surgically sterile (e.g., hysterectomy, tubal ligation) or (amenorrhea >1 year and follicle-stimulating hormone [FSH] >25.8 mIU/mL) and with a negative pregnancy test.
  3. (BMI) of 22.0-35.0 kg/m2 (inclusive).
  4. Be informed of the nature of the trial and provide signed to participate in the trial prior to any trial-specific procedures.
  5. After being shown the high fat meal, understands and accepts that the entire meal should be consumed within 30 minutes.
  6. Be legally competent and able to communicate effectively (in English) with trial personnel.

Exclusion criteria

Exclusion Criteria:

  1. Tobacco cigarette smokers within the last 3 months prior to dosing with trial drug.
  2. Any disease or condition that might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer and cholecystectomy) systems, or any clinical laboratory values assessed as potentially by the investigator .
  3. Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant.
  4. Congenital long syndrome, history of prolonged QT in the 3 months prior to screening.
  5. A corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470 msec (female) or history of risk factors for Torsades de Pointes.
  6. A history of alcoholism or drug addiction within the past 2 years, recent use (in the last month) of any illicit drugs, or positive results from a urine screen for substances of abuse or from an alcohol breath test.
  7. 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.
  8. Severe learning disability, brain damage, or pervasive developmental disorder.
  9. A history of difficulty donating blood or inadequate venous access.
  10. Clinically significant anemia or low (levels \<9 g/dL) at screening, or donation of >250 mL of blood or plasma within the 30 days prior to prior to receiving trial drug or received any blood and plasma for medical/surgical reasons within the 30 days prior to prior to receiving trial drug, or intention to donate blood or plasma within 1 month after receiving trial drug.
  11. History of or current or or C.
  12. History of COVID-19 within 4 weeks prior to Day -1, or positive COVID 19 test, according to standard procedures at the site, at screening or Day 1.
  13. Positive serum pregnancy test (ß-hCG) at screening or positive urine pregnancy test at Day 1 confirmed by a serum pregnancy test result.
  14. Allergies to the trial drug and known allergies to pregnenolone or to corn and corn derivatives.
  15. Use of any prescription or over-the-counter drug therapy, including psychoactive and/or psychotropic medication, herbal, homeopathic, vitamins, minerals, and nutritional supplements, bodybuilding 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).
  16. Use of a drug therapy, or diet or supplements (e.g., St. John's Wort) food and fruit juices (e.g., grapefruit juice) known to induce or inhibit hepatic drug metabolism within 30 days prior to receiving trial drug or during the trial.
  17. Legal status that would interfere with participation.
  18. Unable to follow the restrictions outlined in the protocol.
  19. Ingestion of an drug or product, or participation in a drug trial within a period of 90 days prior to receiving trial drug.
Terms in these criteria, in plain language(10)

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.

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.

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).

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.

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.

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.

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.

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).

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    AEF0117 1.0 mg in fasted condition

    16 participants receive 1 dose of AEF0117 1 mg in fasted condition

    Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition

  • Experimental
    AEF0117 1.0 mg in fed condition

    16 participants receive 1 dose of AEF0117 1 mg fed condition

    Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition

Interventions

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Bioavailibility of AEF0117 (Tlag)

    Tlag is the Time point of first quantifiable concentration after dose administration

    Time frame: up to 312 hours after dosing

Secondary outcomes

  1. 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

  2. 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

  3. Incidence of Treatment-Emergent Adverse Event

    Number of participant reporting at least one Adverse Event

    Time frame: up to 312 hours after AEF0217 dosing

07

Results

Posted Jan 22, 2026

Participant flow

Participant flow — Overall Study
MilestoneAEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed Condition
Started1111
Completed117
Not completed04

Outcome measures

PrimaryCmax 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
Reported as:
Geometric mean · pg/mL
Cmax of AEF0117
pg/mLAEF0117 1.0 mg Once Daily (QD) in Fed ConditionAEF0117 1.0 mg in Fasted Condition
Cmax of AEF01176.87 ± 38.03.76 ± 28.6
Statistical analysis
  • AEF0117 1.0 mg Once Daily (QD) in Fed Condition vs AEF0117 1.0 mg in Fasted Condition · t-test, 2 sided · p = 0.0079 · Ratio of the geometric means: 1.824 · 90% CI 1.321 to 2.518
PrimaryTmax 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
Reported as:
Median · hours
Tmax of AEF0117
hoursAEF0117 1.0 mg Once Daily (QD) in Fed ConditionAEF0117 1.0 mg in Fasted Condition
Tmax of AEF01173.5165 (2.0170 to 6.0000)3.0000 (2.0000 to 3.0000)
PrimaryAUC (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
Reported as:
Geometric mean · hours*pg/mL
AUC (Area Under Curve) t to Last Concentration of AEF0117
hours*pg/mLAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
AUC (Area Under Curve) t to Last Concentration of AEF011761.50 ± 22.034.43 ± 27.8
Statistical analysis
  • AEF0117 1.0 mg in Fed Condition vs AEF0117 1.0 mg in Fasted Condition · t-test, 2 sided · p = <0.0001 · Ratio of geometric means: 1.786 · 90% CI 1.470 to 2.170
SecondaryLowest 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
Reported as:
Mean · pg/mL
Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure
pg/mLAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure373.9108 ± 149.2681154.1652 ± 62.7416
SecondaryTerminal 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
Reported as:
Median · hours
Terminal Elimination Half-life (t1/2) of AEF0117
hoursAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
Terminal Elimination Half-life (t1/2) of AEF0117170.5580 (32.5230 to 212.9730)212.3460 (181.7600 to 242.7210)
PrimaryAUC (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
Reported as:
Geometric mean · hours*pg/mL
AUC (Area Under Curve) t to Infinity Observed of AEF0117
hours*pg/mLAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
AUC (Area Under Curve) t to Infinity Observed of AEF011770.86 ± 23.742.14 ± 26.0
Statistical analysis
  • AEF0117 1.0 mg in Fed Condition vs AEF0117 1.0 mg in Fasted Condition · t-test, 2 sided · p = 0.0002 · Ratio of geometric means: 1.681 · 90% CI 1.382 to 2.046
PrimaryBioavailibility of AEF0117 (Tlag)

Tlag is the Time point of first quantifiable concentration after dose administration

Time frame:
up to 312 hours after dosing
Reported as:
Median · hours
Bioavailibility of AEF0117 (Tlag)
hoursAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
Bioavailibility of AEF0117 (Tlag)0.5000 (0.0000 to 1.0000)0.0000 (0.0000 to 0.0000)
SecondaryIncidence of Treatment-Emergent Adverse Event

Number of participant reporting at least one Adverse Event

Time frame:
up to 312 hours after AEF0217 dosing
Reported as:
Count of participants · Participants
Incidence of Treatment-Emergent Adverse Event
ParticipantsAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
Incidence of Treatment-Emergent Adverse Event36

Adverse events

Collected over from D1 (IP administration) until D14. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AEF0117 1.0 mg in Fed Condition0/11 (0%)0/11 (0%)3/11 (27.3%)
AEF0117 1.0 mg in Fasted Condition0/11 (0%)0/11 (0%)6/11 (54.5%)
Most frequent other events
Most frequent other events
EventAEF0117 1.0 mg in Fed ConditionAEF0117 1.0 mg in Fasted Condition
HeadacheNervous system disorders0/113/11
Brain FogNervous system disorders0/111/11
MalaiseGeneral disorders1/110/11
DizzinessNervous system disorders0/111/11
coordination abnormalNervous system disorders0/111/11
PainGeneral disorders1/110/11
Back painMusculoskeletal and connective tissue disorders1/110/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed ConditionTotal
<=18 years000
Between 18 and 65 years111122
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)AEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed ConditionTotal
Female224
Male9918
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed ConditionTotal
American Indian or Alaska Native000
Asian325
Native Hawaiian or Other Pacific Islander000
Black or African American347
White437
More than one race000
Unknown or Not Reported123
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed ConditionTotal
Hispanic or Latino033
Not Hispanic or Latino11819
Unknown or Not Reported000
Weight
Weight(kg)AEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed ConditionTotal
Mean85.45 ± 11.4681.25 ± 13.6583.35 ± 12.48
Body Mass Index
Body Mass Index(kg/m2)AEF0117 1.0 mg in Fasted ConditionAEF0117 1.0 mg in Fed ConditionTotal
Mean27.195 ± 3.16126.307 ± 3.14526.751 ± 3.110
08

Study locations

1 site
  • Substance Use Research Center
    New York, New York 10032, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05451017
Lead sponsor
Aelis Farma
Responsible party
Sponsor
First posted
Jul 11, 2022
Start date
Jan 4, 2023
Primary completion
Jun 26, 2023
Completion
Jun 28, 2023
Results posted
Jan 22, 2026
Last update
Jan 22, 2026

Study contacts

Margaret Haney, PhD
principal investigator · Substance Use Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lixosicone

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