The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

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

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Cultivate Biologics

Criteria

Inclusion Criteria:

1. Have provided written informed consent

2. Be between the ages of 18 and 55

3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

4. Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session

5. Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session

6. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission

7. Weigh between 110 lbs (50 kg) and 220 lbs (100 kg)

8. Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg

9. Self-report prior experience using cannabis or CBD products, but no cannabis, cannabinoid, or hemp product use in the prior 30 days

10. Have not donated blood in the prior 30 days

11. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last drug administration session

Exclusion Criteria:

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the past 30 days

2. History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures

3. Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant

4. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.

5. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)

6. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing

7. Epilepsy or a history of seizures.

8. Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.