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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05282797
Recruitment Status : Recruiting
First Posted : March 16, 2022
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Anebulo Pharmaceuticals

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
Acute Cannabinoid Intoxication Drug: ANEB-001 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sensation of Feeling High [ Time Frame: Day 1 ]
    Feeling High on a visual analog scale (mm)


Secondary Outcome Measures :
  1. Sensation of Mood [ Time Frame: Day 1 ]
    Mood on a visual analog scale (mm)

  2. Sensation of Calmness [ Time Frame: Day 1 ]
    Calmness on a visual analog scale (mm)

  3. Body sway [ Time Frame: Day 1 ]
    antero-posterior sway (mm);

  4. Sensation of Alertness [ Time Frame: Day 1 ]
    Alertness on a visual analog scale (mm)

  5. Heart Rate [ Time Frame: Day 1 ]
    Heart Rate in beats/min



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05282797


Contacts
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Contact: GJ Groeneveld, MD, PhD +31 71 5246 400 info@chdr.nl
Contact: J Heuberger, PhD +31 71 5246 400 info@chdr.nl

Locations
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Netherlands
Centre for Human Drug Research (CHDR) Recruiting
Leiden, ZH, Netherlands, 2333
Contact: GJ Groeneveld, MD, PhD    +31 71 5246 400    info@chdr.nl   
Sponsors and Collaborators
Anebulo Pharmaceuticals
Investigators
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Principal Investigator: GJ Groeneveld, MD, PhD CHDR
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Responsible Party: Anebulo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05282797    
Other Study ID Numbers: AN01AC11
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No