Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324982
Collaborator
Canopy Growth Corporation (Industry)
30
1
5
33.7
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Placebo
  • Drug: Oral CBG Cannabis
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A within-subjects design.A within-subjects design.
Masking:
Double (Participant, Care Provider)
Masking Description:
Placebo controlled, double blind drug administration
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study, Pharmacokinetics, and Pharmacodynamics of CHI-914 in Healthy Participants
Actual Study Start Date :
Aug 9, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

Drug: Oral Placebo
Placebo will be orally self-administered by study participants.

Experimental: Oral administration of 25mg CBG

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

Drug: Oral CBG Cannabis
CBG cannabis oil will be orally self-administered by study participants.
Other Names:
  • marijuana
  • Experimental: Oral administration of 50mg CBG

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

    Drug: Oral CBG Cannabis
    CBG cannabis oil will be orally self-administered by study participants.
    Other Names:
  • marijuana
  • Experimental: Oral administration of 100mg CBG

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

    Drug: Oral CBG Cannabis
    CBG cannabis oil will be orally self-administered by study participants.
    Other Names:
  • marijuana
  • Experimental: Oral administration of 200mg CBG

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

    Drug: Oral CBG Cannabis
    CBG cannabis oil will be orally self-administered by study participants.
    Other Names:
  • marijuana
  • Outcome Measures

    Primary Outcome Measures

    1. Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) [8 hours]

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

    2. Heart rate [8 hours]

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

    3. Blood Pressure [8 hours]

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

    4. Divided Attention as assessed by the DAT [8 hours]

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

    5. Digit Symbol Substitution Task (DSST) score [8 hours]

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

    6. Paced Auditory Serial Addition Task (PASAT) score [8 hours]

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

    7. Behavioral task performance as assessed by the DRUID app [8 hours]

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

    8. Digit Vigilance Test (response time) [8 hours]

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

    9. Digit Vigilance Test (number of incorrect responses) [8 hours]

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

    10. Go/No-Go Task (response time) [8 hours]

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

    11. Go/No-Go Task (number of incorrect responses) [8 hours]

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

    12. Quantitative levels of CHI-914 (CBG) in blood [8 hours]

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

    13. Quantitative levels of CHI-914 (CBG) in urine [8 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Behavioral Pharmacology Research Unit Baltimore Maryland United States 21224

    Sponsors and Collaborators

    • Johns Hopkins University
    • Canopy Growth Corporation

    Investigators

    • Principal Investigator: Cecilia Bergeria, PhD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05324982
    Other Study ID Numbers:
    • IRB00307925
    First Posted:
    Apr 13, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2022