NCT05324982 · Johns Hopkins University
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
What this study is about
The purpose of the present study is to examine the how the drug moves through the body and how the drug affects the body of cannabigerol (CBG; CHI-914), a naturally occurring chemical constituent of the cannabis plant formulated for taken by mouth consumption, in healthy adults.
View original scientific 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 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.
Interventions
DRUG
Oral Placebo
Placebo will be orally self-administered by study participants.
DRUG
Oral CBG Cannabis
CBG cannabis oil will be orally self-administered by study participants.
Primary outcome measures
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)
Time frame: 8 hours
Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.
Heart rate
Time frame: 8 hours
Heart rate (beats/minute) will be measured while sitting down using the vitals machine.
Blood Pressure
Time frame: 8 hours
Blood pressure (mmHg) will be measured while sitting down using the vitals machine.
Divided Attention as assessed by the DAT
Time frame: 8 hours
Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.
Digit Symbol Substitution Task (DSST) score
Time frame: 8 hours
Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting.
Paced Auditory Serial Addition Task (PASAT) score
Time frame: 8 hours
Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability.
Behavioral task performance as assessed by the DRUID app
Time frame: 8 hours
Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance.
Digit Vigilance Test (response time)
Time frame: 8 hours
Digit Vigilance Test, primary outcome is response time of all trials.
Digit Vigilance Test (number of incorrect responses)
Time frame: 8 hours
Digit Vigilance Test, primary outcome is number of incorrect responses of all trials.
Go/No-Go Task (response time)
Time frame: 8 hours
Go/No-Go Task, primary outcome is response time of all trials.
Go/No-Go Task (number of incorrect responses)
Time frame: 8 hours
Go/No-Go Task, primary outcome is number of incorrect responses of all trials.
Quantitative levels of CHI-914 (CBG) in blood
Time frame: 8 hours
Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).
Quantitative levels of CHI-914 (CBG) in urine
Time frame: 8 hours
Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Baltimore, Maryland
Collaborators
Canopy Growth Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2025 · Source of record for eligibility and locations