Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test
Lead Sponsor:
Anebulo Pharmaceuticals
Conditions:
Acute Cannabinoid Intoxication
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of c...
Detailed Description
This study will evaluate whether ANEB-001 effectively inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC). All cohorts in part A and B of the study will be randomized, double-blind and ...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure
- BMI between 18 and 30 kg/m2
- Minimum weight 50 kg
- Occasional cannabis user
Exclusion
- Evidence of active or chronic condition that could interfere with, or which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
- Clinically significant abnormalities, as judged by the investigator
- Positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody at screening
- Systolic blood pressure greater than 130 or less than 90 mm Hg and diastolic blood pressure greater than 95 or less than 50 mm Hg at screening Abnormal findings in the resting electrocardiogram
- Use of any medications within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol and ibuprofen and topical medications.
- Use of any vitamin, mineral, herbal and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer)
- Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study)
- History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquilizers, or any other addictive agent other than recreative use of THC
- Positive test for drugs of abuse (other than THC) at screening.
- Positive test for drugs of abuse pre-dose
- Clinically significant suicidal ideation in the past 5 years as judged by the investigator or any life-time suicide attempts
- History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.
- History of a clinically significant mood disorder, including but not limited to major depressive disorder, as judged by the investigator.
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05282797
Start Date
December 15 2021
End Date
August 26 2023
Last Update
August 29 2023
Active Locations (1)
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1
Centre for Human Drug Research (CHDR)
Leiden, South Holland, Netherlands, 2333