NCT05324982 Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

Trial Parameters

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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 do

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