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

NCT05282797 | Completed Phase 2

• 1 other identifier: AN01AC11
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cannabinoid Intoxication

Outcome Measures

Primary Outcomes (4)

• Subjective Feeling High

  Feeling High on a visual analog scale (mm)

  Day 1

• Postural stability

  Body sway (mm);

  Day 1

• Subjective Alertness

  Alertness on a visual analog scale (mm)

  Day 1

• Heart Rate

  Heart Rate in beats/min

  Day 1

Secondary Outcomes (10)

• Subjective Mood

  Day 1

• Subjective Calmness

  Day 1

• Feeling of Drug Effect

  Day 1

• Symbol Digit Substitution Test (SDST)

  Day 1

• Visual Verbal Learning Test (VVLT)

  Day 1

Study Arms (16)

Part A - ANEB-001

EXPERIMENTAL

Subjects receive THC and varying amounts of ANEB-001

Drug: ANEB-001

Part A - Placebo

PLACEBO COMPARATOR

Subjects receive THC and placebo

Drug: Placebo

Part B - Cohort 1 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part B - Cohort 1 - Placebo

PLACEBO COMPARATOR

Subjects receive 21 mg of THC and placebo

Drug: Placebo

Part B - Cohort 2 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part B - Cohort 2 - Placebo

PLACEBO COMPARATOR

Subjects receive 21 mg of THC and placebo

Drug: Placebo

Part B - Cohort 3 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part B - Cohort 3 - Placebo

PLACEBO COMPARATOR

Subjects receive 21 mg THC and 1 hour later, placebo

Drug: Placebo

Part B - Cohort 4 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part B - Cohort 4 - Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B - Cohort 5 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part B - Cohort 5 - Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B - Cohort 6 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part B - Cohort 6 - Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part C - Cohort 7 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Part C - Cohort 8 - ANEB-001

EXPERIMENTAL

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

Drug: ANEB-001

Interventions

ANEB-001 DRUG

Experimental Treatment

Part A - ANEB-001; Part B - Cohort 1 - ANEB-001; Part B - Cohort 2 - ANEB-001; Part B - Cohort 3 - ANEB-001; Part B - Cohort 4 - ANEB-001; Part B - Cohort 5 - ANEB-001; Part B - Cohort 6 - ANEB-001; Part C - Cohort 7 - ANEB-001; Part C - Cohort 8 - ANEB-001

Placebo DRUG

Placebo comparator

Part A - Placebo; Part B - Cohort 1 - Placebo; Part B - Cohort 2 - Placebo; Part B - Cohort 3 - Placebo; Part B - Cohort 4 - Placebo; Part B - Cohort 5 - Placebo; Part B - Cohort 6 - Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent prior to any study-mandated procedure
• BMI between 18 and 30 kg/m2
• Minimum weight 50 kg
• Occasional cannabis user

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anebulo Pharmaceuticals: lead

Study Sites (1)

Centre for Human Drug Research (CHDR)

Leiden, South Holland, 2333, Netherlands

Location

Study Officials

• GJ Groeneveld, MD, PhD

  CHDR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: December 15, 2021
• Primary Completion: August 26, 2023
• Study Completion: August 26, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

NL (1)