Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Model
Study Details
Study Description
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 cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for THC intoxication.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A randomized study is planned over a 12 month period to evaluate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC). All cohorts will be randomized, double-blind and placebo-controlled. Randomization is deemed appropriate to avoid selection bias for active compound or placebo treatment. A double-blind and placebo-controlled design is deemed appropriate because of the safety, tolerability and pharmacodynamic assessments that will be performed in this study. By double-blinding the study, bias arising from study subject's or investigator's knowledge about treatment assignment is avoided. The investigator, sponsor team, all site staff and all related parties with direct involvement in study conduct will remain fully blinded throughout the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 100 mg of ANEB-001
|
Drug: ANEB-001
Experimental Treatment
|
| Experimental: 50 mg of ANEB-001
|
Drug: ANEB-001
Experimental Treatment
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo comparator
|
Outcome Measures
Primary Outcome Measures
- Sensation of Feeling High [Day 1]
Feeling High on a visual analog scale (mm)
Secondary Outcome Measures
- Sensation of Mood [Day 1]
Mood on a visual analog scale (mm)
- Sensation of Calmness [Day 1]
Calmness on a visual analog scale (mm)
- Body sway [Day 1]
antero-posterior sway (mm);
- Sensation of Alertness [Day 1]
Alertness on a visual analog scale (mm)
- Heart Rate [Day 1]
Heart Rate in beats/min
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed informed consent prior to any study-mandated procedure
-
BMI between 18 and 30 kg/m2
-
Minimum weight 50 kg
-
Occasional cannabis user
Exclusion Criteria:
-
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 140 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
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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.
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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)
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Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Human Drug Research (CHDR) | Leiden | ZH | Netherlands | 2333 |
Sponsors and Collaborators
- Anebulo Pharmaceuticals
Investigators
- Principal Investigator: GJ Groeneveld, MD, PhD, CHDR
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AN01AC11