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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aelis Farma
• Collaborator: National Institute on Drug Abuse (NIDA)

Criteria

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 weight of 50.0-100.0 kg (inclusive), with a body mass index (BMI) of 18.0-310.0 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.