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Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT05324982
Recruitment Status : Recruiting
First Posted : April 13, 2022
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
Canopy Growth Corporation
Information provided by (Responsible Party):
Johns Hopkins University

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
Behavioral Pharmacology of Cannabis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : August 9, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: 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 Name: 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 Name: 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 Name: marijuana




Primary Outcome Measures :
  1. Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) [ Time Frame: 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 [ Time Frame: 8 hours ]
    Heart rate (beats/minute) will be measured while sitting down using the vitals machine.

  3. Blood Pressure [ Time Frame: 8 hours ]
    Blood pressure (mmHg) will be measured while sitting down using the vitals machine.

  4. Divided Attention as assessed by the DAT [ Time Frame: 8 hours ]
    Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.

  5. Digit Symbol Substitution Task (DSST) score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 8 hours ]
    Digit Vigilance Test, primary outcome is response time of all trials.

  9. Digit Vigilance Test (number of incorrect responses) [ Time Frame: 8 hours ]
    Digit Vigilance Test, primary outcome is number of incorrect responses of all trials.

  10. Go/No-Go Task (response time) [ Time Frame: 8 hours ]
    Go/No-Go Task, primary outcome is response time of all trials.

  11. Go/No-Go Task (number of incorrect responses) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 hours ]
    Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05324982


Contacts
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Contact: Cecilia Bergeria, PhD 410-550-1979 cberge21@jhmi.edu
Contact: Ryan Vandrey, PhD 410-550-4036 rvandrey@jhmi.edu

Locations
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United States, Maryland
Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Cecilia Bergeria, Ph.D.    410-550-1979    cberge21@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Canopy Growth Corporation
Investigators
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Principal Investigator: Cecilia Bergeria, PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05324982    
Other Study ID Numbers: IRB00307925
First Posted: April 13, 2022    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders