A Randomized, Double-Blind, Placebo-Controlled Study, Pharmacokinetics, and Pharmacodynamics of CHI-914 in Healthy Participants
Johns Hopkins University
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.
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. Oral drug administration will be double blind (the participant and research staff will be unaware of the dose administered; though active doses will be fixed in ascending order, placebo will be randomly assigned). Upon enrollment, participants will complete 5 ora…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 scree…
Interventions
- DrugOral Placebo
Placebo will be orally self-administered by study participants.
- DrugOral CBG Cannabis
CBG cannabis oil will be orally self-administered by study participants.
Location
- Behavioral Pharmacology Research UnitBaltimore, Maryland