Marijuana Abuse Clinical Trial
Official title:
The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
Verified date | January 2024 |
Source | Aelis Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 32 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 contraception 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 post-menopausal (amenorrhea >1 year and follicle-stimulating hormone [FSH] >25.8 mIU/mL) and with a negative pregnancy test. 3. Body mass index (BMI) of 22.0-35.0 kg/m2 (inclusive). 4. Be informed of the nature of the trial and provide signed informed consent 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: 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 clinically significant by the investigator . 3. Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant. 4. Congenital long QT 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 hemoglobin (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 HIV or hepatitis B 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 investigational drug or product, or participation in a drug trial within a period of 90 days prior to receiving trial drug. |
Country | Name | City | State |
---|---|---|---|
United States | Substance Use Research Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Aelis Farma | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Peak Plasma Concentration (Cmax) of AEF0117 potential metabolites | Cmax based on serial blood sample collections and plasma concentration after fed conditions relative to fasting conditions | Pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose) | |
Other | Time to maximum plasma concentration (tmax) of AEF0117 potential metabolites | tmax based on serial blood sample collections and plasma after fed conditions relative to fasting conditions | Pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose) | |
Other | AUC of Plasma concentrations of AEF0117 potential metabolites | Area under the plasma concentration versus time curve from time 0 (AUC0-t) based on serial blood sample collections and plasma concentrationafter fed conditions relative to fasting conditions | Pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose) | |
Primary | Cmax of AEF0117 | Peak Plasma Concentration (Cmax) 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 | up to 312 hours after dosing | |
Primary | 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 concentrationafter fed conditions relative to fasting conditions. | up to 312 hours after dosing | |
Primary | Bioavailibility of AEF0117 (tlast) | Time to last measurable plasma concentration (tlast) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions | up to 312 hours after dosing | |
Secondary | AUC (area under curve) of AEF0117 | Area under the plasma concentration based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions | up to 312 hours after dosing | |
Secondary | 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 | up to 312 hours after dosing | |
Secondary | 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 | up to 312 hours after dosing | |
Secondary | Incidence of Treatment-Emergent Adverse Events [safety and tolerability] | Collection of advserve events (AEs), blood pressure (BP), heart rate (RT) and electrocardiogramme (ECG) | up to 312 hours after dosing |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Completed |
NCT00158249 -
Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
|
Phase 2 | |
Completed |
NCT00842985 -
Dronabinol Interactions in Humans
|
N/A | |
Completed |
NCT00484302 -
Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
|
N/A | |
Completed |
NCT00218478 -
Evaluating Responses to Drug-Related Cues Versus Neutral Cues to Understand the Effects of Marijuana Craving - 1
|
Phase 1 | |
Completed |
NCT00227903 -
Therapeutic Substance Abuse Treatment in Pregnancy - 1
|
Phase 2 | |
Completed |
NCT00227864 -
A Brief Marijuana Intervention for Adolescent Women - 1
|
Phase 3 | |
Completed |
NCT00249509 -
Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals
|
Phase 2 | |
Completed |
NCT03717272 -
Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects
|
Phase 2 | |
Completed |
NCT00142961 -
Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder
|
Phase 2 | |
Terminated |
NCT02102230 -
CBT-I for Cannabis Use
|
N/A | |
Completed |
NCT00580671 -
Treatment for Adolescent Marijuana Abuse
|
N/A | |
Completed |
NCT00360269 -
Atomoxetine Treatment for ADHD and Marijuana Dependence
|
Phase 2 | |
Completed |
NCT00227916 -
Motivational Interviews for Incarcerated Teens - 1
|
N/A | |
Completed |
NCT03154567 -
Effects of Stress and Drug-cue Exposure (SCM)
|
Phase 1 | |
Active, not recruiting |
NCT05322941 -
Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD)
|
Phase 2 | |
Completed |
NCT02797990 -
Conflict Between Maternal Autonomy and Child Health in Substance-use
|
N/A | |
Completed |
NCT01762696 -
A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth
|
N/A | |
Completed |
NCT03154580 -
Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users
|
Phase 1 | |
Completed |
NCT00142870 -
Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
|
Phase 2 |