Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants

Launched by JOHNS HOPKINS UNIVERSITY · Apr 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a substance called cannabigerol (CBG), which is found in the cannabis plant and is taken by mouth. The goal is to understand how CBG works in the body and how it affects people. The study will involve healthy adults who will take different doses of CBG (25, 50, 100, and 200 mg) as well as a placebo (a non-active substance) to compare the effects. Each participant will take one dose at a time and then be monitored for 8 hours to see how their body responds.

To be eligible, participants need to be between 18 and 55 years old, in good health, and have no recent cannabis usage. They should also have a body mass index (BMI) between 18 and 30 and not have any significant medical or psychiatric conditions. During the trial, participants can expect a structured environment where they will receive close monitoring and support. It's important to note that those with certain medical histories, recent drug use, or those who are pregnant or nursing cannot participate. This study aims to provide valuable information about the safety and effects of CBG in healthy individuals.

Gender

ALL

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.