Status:
RECRUITING
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Canopy Growth Corporation
Conditions:
Behavioral Pharmacology of Cannabis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of cannabigerol (CBG; CHI-914), a naturally occurring chemical constituent of the cannabis plant formulated for...
Detailed Description
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of cannabigerol (CBG; CHI-914), a naturally occurring chemical constituent of the cannabis plant formulated for...
Eligibility Criteria
Inclusion
- Have provided written informed consent.
- Be between the ages of 18 and 55.
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests.
- Test negative for recent cannabis use in urine at the screening visit and again upon admission for the experimental sessions.
- Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session.
- 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.
- Have a body mass index (BMI) in the range of 18 to 30 kg/m2.
- 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.
- Self-report prior experience using cannabis, but no use of any cannabinoid products in the prior 30 days.
- Have not donated blood in the prior 30 days.
Exclusion
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the 30-days prior to the Screening Visit.
- 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.
- Endorse suicidal intent as indexed by endorsement of questions #4 and #5 on the C-SSRS.
- Use of an over-the-counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- Epilepsy or a history of seizures.
- Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.
- Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception.
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05324982
Start Date
August 9 2022
End Date
December 1 2025
Last Update
June 25 2025
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224