NCT05324982 Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
| NCT ID | NCT05324982 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Behavioral Pharmacology of Cannabis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-08-09 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2022-08-09 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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 the experimental sessions. 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. Have a body mass index (BMI) in the range of 18 to 30 kg/m2. 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, but no use of any cannabinoid products in the prior 30 days. 10. Have not donated blood in the prior 30 days. Exclusion Criteria: 1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the 30-days prior to the Screening Visit. 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. Endorse suicidal intent as indexed by endorsement of questions #4 and #5 on the C-SSRS. 4. 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. 5. 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. 6. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina). 7. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing. 8. Epilepsy or a history of seizures. 9. Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk. 10. 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.
Contact & Investigator
Cecilia Bergeria, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05324982 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Behavioral Pharmacology of Cannabis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05324982 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05324982 currently recruiting?
Yes, NCT05324982 is actively recruiting participants. Contact the research team at cberge21@jhmi.edu for enrollment information.
Where is the NCT05324982 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05324982 clinical trial?
NCT05324982 is sponsored by Johns Hopkins University. The principal investigator is Cecilia Bergeria, PhD at Johns Hopkins University. The trial plans to enroll 30 participants.