Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
NCT05324982 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-06-25
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.
Conditions
- Behavioral Pharmacology of Cannabis
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.
Sponsors & Collaborators
-
Canopy Growth Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Cecilia Bergeria, PhD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-09
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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