Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants (NCT05324982) | Clinical Trial Compass
RecruitingPhase 1
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
United States30 participantsStarted 2022-08-09
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
Exclusion criteria
What they're measuring
1
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)
Timeframe: 8 hours
2
Heart rate
Timeframe: 8 hours
3
Blood Pressure
Timeframe: 8 hours
4
Divided Attention as assessed by the DAT
Timeframe: 8 hours
5
Digit Symbol Substitution Task (DSST) score
Timeframe: 8 hours
6
Paced Auditory Serial Addition Task (PASAT) score
Timeframe: 8 hours
7
Behavioral task performance as assessed by the DRUID app
Timeframe: 8 hours
8
Digit Vigilance Test (response time)
Timeframe: 8 hours
9
Digit Vigilance Test (number of incorrect responses)
. 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.