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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

Tracking Information
First Submitted Date  ICMJE March 8, 2022
First Posted Date  ICMJE March 16, 2022
Last Update Posted Date March 16, 2022
Actual Study Start Date  ICMJE December 15, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2022)
Sensation of Feeling High [ Time Frame: Day 1 ]
Feeling High on a visual analog scale (mm)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2022)
  • Sensation of Mood [ Time Frame: Day 1 ]
    Mood on a visual analog scale (mm)
  • Sensation of Calmness [ Time Frame: Day 1 ]
    Calmness on a visual analog scale (mm)
  • Body sway [ Time Frame: Day 1 ]
    antero-posterior sway (mm);
  • Sensation of Alertness [ Time Frame: Day 1 ]
    Alertness on a visual analog scale (mm)
  • Heart Rate [ Time Frame: Day 1 ]
    Heart Rate in beats/min
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Model
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Cannabinoid Intoxication
Intervention  ICMJE
  • Drug: ANEB-001
    Experimental Treatment
  • Drug: Placebo
    Placebo comparator
Study Arms  ICMJE
  • Experimental: 100 mg of ANEB-001
    Intervention: Drug: ANEB-001
  • Experimental: 50 mg of ANEB-001
    Intervention: Drug: ANEB-001
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: GJ Groeneveld, MD, PhD +31 71 5246 400 info@chdr.nl
Contact: J Heuberger, PhD +31 71 5246 400 info@chdr.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05282797
Other Study ID Numbers  ICMJE AN01AC11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anebulo Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Anebulo Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: GJ Groeneveld, MD, PhD CHDR
PRS Account Anebulo Pharmaceuticals
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP