Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

Conditions

• Behavioral Pharmacology of Cannabis

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Oral Placebo — DRUG
  Placebo will be orally self-administered by study participants.
• Oral CBG Cannabis — DRUG
  CBG cannabis oil will be orally self-administered by study participants.

Study Details

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.

Key Dates

Start date

Aug 9, 2022

Status verified

Jun 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Placebo Comparator: Placebo
  Single acute administration of oral Placebo liquid (MCT oil).
• Experimental: Oral administration of 25mg CBG
  Single acute administration of 25mg CBG suspended in MCT oil.
• Experimental: Oral administration of 50mg CBG
  Single acute administration of 50mg CBG suspended in MCT oil.
• Experimental: Oral administration of 100mg CBG
  Single acute administration of 100mg CBG suspended in MCT oil.
• Experimental: Oral administration of 200mg CBG
  Single acute administration of 200mg CBG suspended in MCT oil.

Primary Outcome Measure

Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) [ Time Frame: 8 hours ]

Central Contacts

• Cecilia Bergeria, PhD
  410-550-1979
  [email protected]
• Ryan Vandrey, PhD
  410-550-4036
  [email protected]

Locations (1)

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