A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to investigate the bioavailability of Cannabidiol (CBD) and Tetrahydrocannabinol (THC) in an emulsion product against a comparator product. Thirty-two participants will be randomized into a single-center, double-blind, parallel trial. Participants will be dosed in clinic and blood and urine samples will be taken over a 12-hour period. Blood and urine samples will also be collected for 48 hours post-dose at check-in visits. Questionnaires regarding drug effects and cognitive function will also be completed following each blood sampling. Participants who consumed the comparator product will be asked to return to the clinic following a wash-out period of at least 45 days to consume the emulsion product in-clinic and complete questionnaires at the same specified time points over a 12-hour period.

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

Details

• Lead Sponsor: New Age Ventures LLC
• Collaborator: KGK Science Inc.

Criteria

Inclusion Criteria:

1. Provide voluntary, written informed consent to participate in the study

2. Between 18 and 45 years of age at screening

3. Occasional users of Cannabis: Have consumed cannabis product at least once in the past 6 months and at least 4 times in their lifetime and have experienced psychotropic effects without severe adverse events (short term paranoia, belligerence, extreme hallucinations) requiring medical interventions. Eligibility will be determined on a case by case basis by the QI.

4. Must agree to a 30-day washout of cannabis products prior to baseline.

5. Willingness to complete questionnaires, records and diaries associated with the study

6. Have a Body Mass Index (BMI) in the range of 19.0 to 29.9 kg/m2 at baseline

7. Be willing to provide blood over a 12 h period via an Intravenous (IV) catheter

8. Blood pressure at screening does not exceed a systolic blood pressure (SBP) of 140 mmHg and a diastolic blood pressure (DBP) of 90 mmHg

9. Agree to refrain from smoking tobacco products, including e-cigarettes and vaporizers or consume alcohol 24 hrs prior to their baseline visit and until completion of the study period.

10. Men who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the end of the study and report any pregnancies. If a subject's partner becomes pregnant during his participation in the study or within 30 days after he has completed his last drug administration, he must inform the QI immediately

11. Female participant is not of child bearing potential, which is defined as females who have had a hysterectomy or bilateral oophorectomy, bilateral tubal ligation or natural menopause (have not had menses for > 1 year, as confirmed by measurement of serum FSH ≥ 40 IU/L at screening visit) Or,

Females of childbearing potential must agree to abstain from heterosexual intercourse or use two methods of contraception for 30 days prior to first treatment and for 30 days after the last treatment. Subjects must have a negative urine pregnancy test result at screening, baseline and visit 5. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

• Double-barrier method

• Intrauterine devices

• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)

• Vasectomy of partner at least 6- months prior to screening (Female subjects whose partners who have had a vasectomy must verbally confirm that their partner's vasectomy was confirmed to be successful by previous assessment of semen samples)

12. Agree not to donate blood within 30 days after visit 2, visit 3, visit 4 and visit 5

13. Agrees to refrain from consuming supplements in section 5.3.2 during the study

14. Agrees not to drive or operate heavy machinery if feeling dizzy or drowsy following drug administration until full mental alertness is regained after treatment visits

15. Agrees to provide information of two adult contacts to be reached in the event of transportation requirements from the clinic to their home after the study visits

16. Healthy as determined by the following criteria: laboratory results, medical history, physical exam, meeting all the inclusion criteria, not meeting any of the exclusion criteria and not on any concomitant medications listed in Section 5.3. Eligibility will be assessed by the QI based on the above.

Exclusion Criteria:

1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial

2. Clinically significant abnormal laboratory results at screening as determined by the QI.

3. Verbal confirmation of hepatic or pancreatic malfunctions

4. Verbal confirmation of use of medicinal or recreational products containing CBD/THC in the past 1 month, for participants that have consumed CBD or THC containing products prior to 1 month, eligibility will be assessed by the QI on a case by case basis depending on frequency and amount.

5. Verbal confirmation of use of hemp seeds or hemp oil in the past 1 month, for participants that have consumed hemp seeds or hemp oil prior to 1 month, eligibility will be assessed by the QI on a case by case basis depending on frequency and amount.

6. Verbal confirmation of habitual use of cannabis for medical or recreational purposes:

>4 times a month. For participants who have consumed cannabis products ≤4 times a month, eligibility will be assessed by the QI depending on dose and frequency of use and self reported adverse events

7. Tongue piercings and/or mouth jewelry

8. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable after an assessment by QI

9. History (within the past 5 years) of or current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis of substance dependence. For participants who have a history of substance dependence greater than 5 years ago, eligibility will be assessed on a case by case basis by the QI.

10. Currently seeking or participating in treatment for substance-related disorders

11. History of participation in treatment for substance-related disorders, including successful completion of such treatment within the past 5 years. For participants who have a sought treatment for substance abuse greater than 5 years ago, eligibility will be assessed on a case by case basis by the QI.

12. Clinically significant history of or presence of any clinically significant oral or gastrointestinal pathology (e.g. mouth ulcers, chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to baseline (visit 2) and visit 5.

13. Use of prescribed or over the counter medication which in the opinion of QI will interfere with study results or safety of the subject. Please refer to Section 5.3.1 and 5.3.2.

14. Verbal confirmation of current or history of bleeding disorders. Will be assessed by QI on a case by case basis depending on the disorder

15. Participation in a clinical research trial within 30 days prior to randomization

16. Allergy or sensitivity to investigational product and MCT-diluted cannabis oil ingredients

17. Verbal confirmation of diabetes and use of diabetes medication. However, eligibility will be assessed by the QI on a case by case basis based on dose and frequency of medication.

18. Current or previous history of clinically diagnosed neuropsychiatric disorders as per qualified investigator's (QI) opinion

19. Presence of drugs: amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), nicotine (cotinine), alcohol and THC and metabolites in urine, at screening, baseline and visit 5 (if visit 5 is applicable).

20. Personal or family history (immediate family) of psychosis: including schizophrenia and affective psychosis

21. History of suicidal ideation attempts and/or behaviour

22. Individuals who are cognitively impaired and/or who are unable to give informed consent 23. Verbal confirmation of any autoimmune disease or immune-compromised (i.e. use of anti-rejection medication, rheumatoid arthritis,)

24. Positive laboratory results for HIV, Hepatitis B or C as assessed at screening.

25. Any current or recent active and unstable medical condition that could potentially affect the study objective or adversely affect the participant's ability to complete the study or safety of the subject as per the QI