Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test

NCT ID: NCT05282797

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2023-08-26

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 acute cannabinoid intoxication.

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 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. Part C does not include a placebo group and will therefore not be blinded.

Conditions

Acute Cannabinoid Intoxication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A - ANEB-001

Subjects receive THC and varying amounts of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part A - Placebo

Subjects receive THC and placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part B - Cohort 1 - ANEB-001

Subjects receive 21 mg of THC and 30 mg of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part B - Cohort 1 - Placebo

Subjects receive 21 mg of THC and placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part B - Cohort 2 - ANEB-001

Subjects receive 21 mg of THC and 10 mg of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part B - Cohort 2 - Placebo

Subjects receive 21 mg of THC and placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part B - Cohort 3 - ANEB-001

Subjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part B - Cohort 3 - Placebo

Subjects receive 21 mg THC and 1 hour later, placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part B - Cohort 4 - ANEB-001

Subjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part B - Cohort 4 - Placebo

Subjects receive 40 mg of THC and 1 hour later, placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part B - Cohort 5 - ANEB-001

Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part B - Cohort 5 - Placebo

Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part B - Cohort 6 - ANEB-001

Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, 10 mg of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part B - Cohort 6 - Placebo

Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Part C - Cohort 7 - ANEB-001

Subjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Part C - Cohort 8 - ANEB-001

Subjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001

Group Type: EXPERIMENTAL

ANEB-001

Intervention Type: DRUG

Experimental Treatment

Interventions

ANEB-001

Experimental Treatment

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anebulo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GJ Groeneveld, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHDR

Locations

Centre for Human Drug Research (CHDR)

Leiden, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

AN01AC11

Identifier Type: -

Identifier Source: org_study_id