Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

NCT ID: NCT05324982

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2025-12-31

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.

Detailed 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 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG). Doses were selected based on current retail CBG products and web-based surveys of CBG use among current CBG product users. Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic drug effects. Blood specimens will be obtained throughout these 8 hours to characterize the pharmacokinetics of CBG. Pharmacodynamic assessments including subjective drug effects, cognitive performance testing, and vital signs will also be collected for 8 hours post-drug administration. Experimental test sessions will be separated by at least 1 week to allow for sufficient drug washout between doses. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Oral Placebo

Intervention Type: DRUG

Placebo will be orally self-administered by study participants.

Oral administration of 25mg CBG

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

Group Type: EXPERIMENTAL

Oral CBG Cannabis

Intervention Type: DRUG

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

Oral administration of 50mg CBG

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

Group Type: EXPERIMENTAL

Oral CBG Cannabis

Intervention Type: DRUG

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

Oral administration of 100mg CBG

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

Group Type: EXPERIMENTAL

Oral CBG Cannabis

Intervention Type: DRUG

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

Oral administration of 200mg CBG

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

Group Type: EXPERIMENTAL

Oral CBG Cannabis

Intervention Type: DRUG

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

Interventions

Oral Placebo

Placebo will be orally self-administered by study participants.

Intervention Type: DRUG

Oral CBG Cannabis

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

Intervention Type: DRUG

Other Intervention Names

marijuana

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 donated blood in the prior 30 days.

Exclusion Criteria

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the 30-days prior to the Screening Visit.

2. 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.

3. Endorse suicidal intent as indexed by endorsement of questions #4 and #5 on the C-SSRS.

4. 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.

5. 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.

6. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).

7. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

8. Epilepsy or a history of seizures.

9. Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canopy Growth Corporation

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia Bergeria, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cecilia Bergeria, PhD

Role: CONTACT

cberge21@jhmi.edu

410-550-1979

Ryan Vandrey, PhD

Role: CONTACT

rvandrey@jhmi.edu

410-550-4036

Facility Contacts

Cecilia Bergeria, Ph.D.

Role: primary

cberge21@jhmi.edu

410-550-1979

Other Identifiers

IRB00307925

Identifier Type: -

Identifier Source: org_study_id