Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The oral bio-availability of cannabidiol (CBD) is low due to poor water solubility and susceptibility to extensive first pass metabolism, resulting in relative bio-availability of 6%.This project is designed to evaluate the plasma concentration vs. time profile of a self emulsifying drug delivery system termed Long Chain Nano Lipospheres (LNL) for enhancing the oral bio-availability of cannabidiol (CBD). The main goal of this study is to evaluate the bio-equivalence of CBD in the LNL product, compared to CBD in a sesame oil vehicle and CBD without any formulation, in powder form. Bio-equivalence is measured by AUC 0-24h, Tmax and Cmax.

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

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

1. Men 18 through 45 years of age with body mass index in the range of: 19 through 30 kg/m2.

2. Participants should be able to ingest and absorb oral medications.

3. Subjects must be in good health as determined by medical history, vital signs measurements, physical examination (routine examination performed by the general physician), and clinical laboratory tests (blood count and biochemistry conducted in the Health maintenance organization in Israel( "kupat holim").

4. Potential participants will undergo a screening/explanatory interview in which their compatibility will be examined. The screening interview will be held prior to the first day of trial (at least during the near month preceding the first day of trial).

5. Subjects must be able to understand and comply with the requirements of the study (e.g. all medication, dietary, and alcohol restrictions).

6. Subjects must provide written informed consent to participate in the study after reading the information and consent form, and after having an opportunity to discuss the study with the investigator.

7. Subjects must complete the screening process within 4 weeks prior to the admission visit.

Exclusion Criteria:

1. Previous participation in an research trial involving administration of any of the investigated compounds within one month prior to the current study.

2. The subject is suffering from, or has a clinically significant history of, one or more of the following: impaired glucose tolerance, diabetes mellitus, renal disease, edema, stroke or neurological disorder, rheumatological disorder (including arthritis, joint or tendon abnormalities), pulmonary disorder (including a personal history of asthma, but excluding resolved pediatric asthma), hepatic disorder, has a personal history of seizures, history of psychosis any addictive or other psychiatric disease disorder or a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject by participation in the study.

3. The subject has a known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 or 2.

4. Any history of adverse events associated with cannabis intoxication or dependence.

5. A subject that has used one of the forbidden drugs, substances or foods as follows:

• Any investigational product (THC or/and CBD ingestion or smoking) within one month preceding the study.

• Any prescription or non-prescription medication (including herbal remedies, vitamins or dietary supplements) or vaccine within 14 days of the first day of study drug administration (Day 1) or within 5 half-lives before the first day of study drug administration, whichever is longer.

Exceptions are locally acting medications (eg, topical creams), which are not allowed within 5 days of study drug administration, and the occasional use of acetaminophen (up to 3 g/day) and ibuprofen (up to 1200 mg/day).

• Consumption of grapefruit, grapefruit juice, Seville oranges, pomelo containing products, within the 14 days prior to Day -1 and then throughout the entire study.

• Consumption of excessive amounts of alcoholic beverages, defined as >3 drinks per day (beer, wine, or distilled spirits), or unwilling to comply with the restricted use of alcohol during the study (48 hours prior to admission and throughout the study), who have history of alcoholism.

6. Subject that has any condition that may possibly interfere with drug absorption, distribution, metabolism, or excretion (eg, previous surgery on the gastrointestinal tract [including removal of parts of stomach, bowel, liver, gall bladder, or pancreas] or stomach banding).

7. Exhausting physical exercise 48 hours prior to drug administration.

8. The subject does not agree to abstain from excessive caffeine and xanthine containing foods and beverages (ie, equivalent to >4 cups brewed coffee per day) from 48hr prior to Day -1 and throughout the entire study.

9. Those who had donated >0.5 L blood within 30 days of study.

10. Abnormal blood pressure and heart rate values according to the following criteria:

• The subject has a supine pulse rate outside of the range of 40 to 100 bpm (following at least a 10-minute rest) measured at screening or Day -1.

• The subject has a supine blood pressure outside of the range of 90 to 139 mm Hg systolic or 50 to 89 mm Hg diastolic (following at least a 10 minute rest) measured at screening or Day-1. Note: The blood pressure measurement may be repeated up to 3 times to meet eligibility requirements. In this case, the average of these 3 measurements must meet eligibility criteria.

11. A subject with a clinically significant history of drug allergies (including cannabis extracts, ethanol, or sesame oil), drug hypersensitivity or history of idiosyncratic reactions to any drug.

12. History of abuse of any drug/chemical.

13. Inability to relate to and/or cooperate with the investigators.

14. A subject with any other condition, which, in the opinion of the investigator, makes the subject inappropriate for the study.