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3ß-(4-methoxybenzyloxy)pregn-5-en-20-one for Cannabis Abuse

Phase 1
Waitlist Available
Led By Margaret Haney, PhD
Research Sponsored by Aelis Farma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight of 50.0-100.0 kg (inclusive), with a body mass index (BMI) of 18.0-310.0 kg/m2 (inclusive).
Healthy, non-smoking male or female of any race, 18 to 55 years old, both inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose)
Awards & highlights

Study Summary

This trial will test the effect of food on the absorption of AEF0117, an investigational new study drug that has shown promise in early studies as a safe and effective treatment for cannabis abuse disorders.

Who is the study for?
Healthy adults aged 18-55, non-smokers with a BMI of 22.0-35.0 kg/m2 can join this trial. They must use effective contraception and not plan pregnancy or sperm donation during the trial. Participants should understand English, be able to eat a high-fat meal quickly, and have no history of serious drug abuse or mental illness.Check my eligibility
What is being tested?
The study tests how food affects the absorption of AEF0117, a potential treatment for cannabis abuse disorder. It compares how well the body absorbs the drug when taken with food versus without food (fasting) in healthy volunteers.See study design
What are the potential side effects?
While specific side effects are not listed here, previous studies show that AEF0117 is generally safe and tolerable. However, as with any medication, there may be risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is between 50 and 100 kg, and my BMI is between 18 and 31.
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I am a healthy, non-smoking person aged 18 to 55.
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I will use effective birth control throughout the trial.
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I will not donate sperm or plan a pregnancy during the trial.
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I agree to use condoms and spermicide as birth control.
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I am a woman who cannot become pregnant because I am either surgically sterile or post-menopausal.
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I can legally make my own decisions and can communicate in English with the trial team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bioavailibility of AEF0117 (tlast)
Cmax of AEF0117
Tmax of AEF0117
Secondary outcome measures
AUC (area under curve) of AEF0117
Incidence of Treatment-Emergent Adverse Events [safety and tolerability]
Lowest Peak Plasma (Cmin) of AEF0117 plasma exposure
+1 more
Other outcome measures
AUC of Plasma concentrations of AEF0117 potential metabolites
Peak Plasma Concentration (Cmax) of AEF0117 potential metabolites
Time to maximum plasma concentration (tmax) of AEF0117 potential metabolites

Trial Design

2Treatment groups
Experimental Treatment
Group I: AEF0117 1.0 mg once daily (QD) in fed conditionExperimental Treatment1 Intervention
16 participants receive 1 dose of AEF0117 1 mg fed condition
Group II: AEF0117 1.0 mg in fasted conditionExperimental Treatment1 Intervention
16 participants receive 1 dose of AEF0117 1 mg in fasted condition

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Aelis FarmaLead Sponsor
9 Previous Clinical Trials
642 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,601 Total Patients Enrolled
9 Trials studying Cannabis Abuse
335,134 Patients Enrolled for Cannabis Abuse
Margaret Haney, PhDPrincipal InvestigatorSubstance Use Research Center
2 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition Clinical Trial Eligibility Overview. Trial Name: NCT05451017 — Phase 1
Cannabis Abuse Research Study Groups: AEF0117 1.0 mg in fasted condition, AEF0117 1.0 mg once daily (QD) in fed condition
Cannabis Abuse Clinical Trial 2023: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition Highlights & Side Effects. Trial Name: NCT05451017 — Phase 1
3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05451017 — Phase 1
Cannabis Abuse Patient Testimony for trial: Trial Name: NCT05451017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities still open for this clinical experiment?

"As shown on clinicaltrials.gov, recruitment for this specific trial has concluded; initially posted in November 1st, 2022 and last updated three days later. Despite the closure of this study, 117 other medical trials are presently recruiting patients."

Answered by AI

Are septuagenarians admissible for this clinical trial?

"The requirements for this research stipulate that patients must be aged between 18 and 55. Conversely, 15 separate clinical trials are available to minors while 47 studies seek out those older than 65 years of age."

Answered by AI

Do I qualify to participate in this clinical investigation?

"This trial seeks to enrol 32 individuals between 18 and 55 years old who are battling with hashish addiction."

Answered by AI

Has the FDA accepted 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one for use in an empty stomach?

"The safety of 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one has been rated a 1 on our scale, due to the limited amount of clinical data available as this is an exploratory Phase 1 trial."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Substance Use Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have serious weed use issues.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
2023. "The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05451017.
~2 spots leftby Jun 2024
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