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

August 28, 2023 updated by: Anebulo Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of CB1 Antagonist ANEB-001 in Healthy Occasional Cannabis Users in a THC Challenge Test.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • ZH
      • Leiden, ZH, Netherlands, 2333
        • Centre for Human Drug Research (CHDR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part B - Cohort 1 - ANEB-001
Subjects receive 21 mg of THC and 30 mg of ANEB-001
Drug: ANEB-001
Experimental Treatment
Experimental: Part B - Cohort 2 - ANEB-001
Subjects receive 21 mg of THC and 10 mg of ANEB-001
Drug: ANEB-001
Experimental Treatment
Experimental: Part A - ANEB-001
Subjects receive THC and varying amounts of ANEB-001
Drug: ANEB-001
Experimental Treatment
Placebo Comparator: Part A - Placebo
Subjects receive THC and placebo
Drug: Placebo
Placebo comparator
Placebo Comparator: Part B - Cohort 1 - Placebo
Subjects receive 21 mg of THC and placebo
Drug: Placebo
Placebo comparator
Placebo Comparator: Part B - Cohort 2 - Placebo
Subjects receive 21 mg of THC and placebo
Drug: Placebo
Placebo comparator
Experimental: Part B - Cohort 3 - ANEB-001
Subjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001
Drug: ANEB-001
Experimental Treatment
Placebo Comparator: Part B - Cohort 3 - Placebo
Subjects receive 21 mg THC and 1 hour later, placebo
Drug: Placebo
Placebo comparator
Experimental: Part B - Cohort 4 - ANEB-001
Subjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001
Drug: ANEB-001
Experimental Treatment
Placebo Comparator: Part B - Cohort 4 - Placebo
Subjects receive 40 mg of THC and 1 hour later, placebo
Drug: Placebo
Placebo comparator
Experimental: Part B - Cohort 5 - ANEB-001
Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001
Drug: ANEB-001
Experimental Treatment
Placebo Comparator: Part B - Cohort 5 - Placebo
Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001
Drug: Placebo
Placebo comparator
Experimental: 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
Drug: ANEB-001
Experimental Treatment
Placebo Comparator: Part B - Cohort 6 - Placebo
Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo
Drug: Placebo
Placebo comparator
Experimental: Part C - Cohort 7 - ANEB-001
Subjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001
Drug: ANEB-001
Experimental Treatment
Experimental: Part C - Cohort 8 - ANEB-001
Subjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001
Drug: ANEB-001
Experimental Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Day 1
Heart Rate in beats/min
Day 1
Subjective Feeling High
Time Frame: Day 1
Feeling High on a visual analog scale (mm)
Day 1
Postural stability
Time Frame: Day 1
Body sway (mm);
Day 1
Subjective Alertness
Time Frame: Day 1
Alertness on a visual analog scale (mm)
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feeling of Drug Effect
Time Frame: Day 1
Feeling of drug effect on a visual analog scale (mm)
Day 1
Subjective Mood
Time Frame: Day 1
Mood on a visual analog scale (mm)
Day 1
Subjective Calmness
Time Frame: Day 1
Calmness on a visual analog scale (mm)
Day 1
Symbol Digit Substitution Test (SDST)
Time Frame: Day 1
Part C Only
Day 1
Visual Verbal Learning Test (VVLT)
Time Frame: Day 1
Part C Only
Day 1
Timed Up-and-Go test (TUG)
Time Frame: Day 1
Part C Only
Day 1
Alternate Finger Tapping (AFT)
Time Frame: Day 1
Part C Only
Day 1
Basic Symptom Inventory (BSI)
Time Frame: Day 1
Part C Only
Day 1
Brief Psychiatric Rating Scale (BPRS)
Time Frame: Day 1
Part C Only
Day 1
Clinical Global Impression of Severity (CGIS)
Time Frame: Day 1
Part C Only
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anebulo Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: GJ Groeneveld, MD, PhD, CHDR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AN01AC11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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