RECRUITING

Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study, Pharmacokinetics, and Pharmacodynamics of CHI-914 in Healthy Participants

Quick Facts

Study Start:2022-08-09

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05324982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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

Study Contact

Cecilia Bergeria, PhD

CONTACT

410-550-1979

cberge21@jhmi.edu

Ryan Vandrey, PhD

CONTACT

410-550-4036

rvandrey@jhmi.edu

Principal Investigator

Cecilia Bergeria, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Cecilia Bergeria, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-09

Study Completion Date2025-06

Study Record Updates

Study Start Date2022-08-09

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Behavioral Pharmacology of Cannabis