Actively Recruiting
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
Led by Johns Hopkins University · Updated on 2025-06-25
30
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Canopy Growth Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 oral consumption, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design.Upon enrollment, participants will complete 5 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic drug effects. This work will provide novel data on the pharmacokinetics, pharmacodynamic effects, and safety of acute oral CBG dose administration in humans.
CONDITIONS
Official Title
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
C
Cecilia Bergeria, PhD
CONTACT
R
Ryan Vandrey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here