Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

NCT05324982 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00307925
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral Pharmacology of Cannabis

Outcome Measures

Primary Outcomes (13)

• Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)

  Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

  8 hours

• Heart rate

  Heart rate (beats/minute) will be measured while sitting down using the vitals machine.

  8 hours

• Blood Pressure

  Blood pressure (mmHg) will be measured while sitting down using the vitals machine.

  8 hours

• Divided Attention as assessed by the DAT

  Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.

  8 hours

• Digit Symbol Substitution Task (DSST) score

  Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting.

  8 hours

• Paced Auditory Serial Addition Task (PASAT) score

  Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability.

  8 hours

• Behavioral task performance as assessed by the DRUID app

  Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance.

  8 hours

• Digit Vigilance Test (response time)

  Digit Vigilance Test, primary outcome is response time of all trials.

  8 hours

• Digit Vigilance Test (number of incorrect responses)

  Digit Vigilance Test, primary outcome is number of incorrect responses of all trials.

  8 hours

• Go/No-Go Task (response time)

  Go/No-Go Task, primary outcome is response time of all trials.

  8 hours

• Go/No-Go Task (number of incorrect responses)

  Go/No-Go Task, primary outcome is number of incorrect responses of all trials.

  8 hours

• Quantitative levels of CHI-914 (CBG) in blood

  Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).

  8 hours

• Quantitative levels of CHI-914 (CBG) in urine

  Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).

  8 hours

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Single acute administration of oral Placebo liquid (MCT oil).

Drug: Oral Placebo

Oral administration of 25mg CBG

EXPERIMENTAL

Single acute administration of 25mg CBG suspended in MCT oil.

Drug: Oral CBG Cannabis

Oral administration of 50mg CBG

EXPERIMENTAL

Single acute administration of 50mg CBG suspended in MCT oil.

Drug: Oral CBG Cannabis

Oral administration of 100mg CBG

EXPERIMENTAL

Single acute administration of 100mg CBG suspended in MCT oil.

Drug: Oral CBG Cannabis

Oral administration of 200mg CBG

EXPERIMENTAL

Single acute administration of 200mg CBG suspended in MCT oil.

Drug: Oral CBG Cannabis

Interventions

Oral Placebo DRUG

Placebo will be orally self-administered by study participants.

Placebo

Oral CBG Cannabis DRUG

CBG cannabis oil will be orally self-administered by study participants.

Also known as: marijuana

Oral administration of 100mg CBG; Oral administration of 200mg CBG; Oral administration of 25mg CBG; Oral administration of 50mg CBG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Self-report prior experience using cannabis, but no use of any cannabinoid products in the prior 30 days.
• Have not donated blood in the prior 30 days.

You may not qualify if:

• 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.
• Epilepsy or a history of seizures.
• Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.
• Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canopy Growth Corporation: collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Interventions

nabiximols

Study Officials

• Cecilia Bergeria, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Bergeria, PhD

CONTACT

410-550-1979; cberge21@jhmi.edu

Ryan Vandrey, PhD

CONTACT

410-550-4036; rvandrey@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Placebo controlled, double blind drug administration
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A within-subjects design.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: August 9, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)