Clinical Trial on Pharmacokinetics and Tolerability of AP707

Sponsor
CannaXan GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT05267769
Collaborator
(none)
12
1
1
1.1
11.4

Study Details

Study Description

Brief Summary

Brief Summary:This study aims to investigate the uptake of AP707, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Pharmacokinetic parameters and tolerability of AP707 is studied over 24 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Clinical Trial on Pharmacokinetics and Tolerability of AP707
Actual Study Start Date :
Mar 2, 2022
Actual Primary Completion Date :
Apr 3, 2022
Actual Study Completion Date :
Apr 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Verum

AP707 single dose oromucosal application

Drug: AP707
Preparation of Cannabis flowers (Cannabis flos)
Other Names:
  • THC
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluation of pharmacokinetic parameter of THC (area under the curve) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    2. Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    3. Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    Secondary Outcome Measures

    1. Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product

    2. Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    3. Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    4. Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    5. Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope) [24 hours]

      Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product

    6. Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    7. Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    8. Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    9. Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    10. Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    11. Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    12. Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    13. Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope) [24 hours]

      Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product

    14. Adverse events (AE) [24 hours]

      Number and severity of adverse events (AE)

    15. Psychotropic drug effects measured by questionnaire [24 hours]

      Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale (on a scale from 0 to 10, where 0 means "not at all" (no agreement) and 10 means "extremely" (strongest agreement).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Signed and dated informed consent form

    2. Male at the age of 30 - 60 years at study start

    3. Body mass index of 18 to 30 kg/m2

    4. Non-smoker, no use of any tobacco products,

    5. Good general health status (Karnofsky Score = 100; see Annex 1, page 59)

    6. Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (QTcF < 450 ms)

    7. Physical examination, medical history without exclusionary findings

    8. Pulse rate between 50 and 90 bpm

    9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg

    10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges

    11. Lab value for renal function (S-Creatinine, eGFR according to CKD-EPI) within normal range

    12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody

    13. Negative test result of urine screening for Cannabis and substance abuse

    Exclusion Criteria:
    1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure

    2. Use of Cannabis products within the last 8 weeks

    3. Use of opioids

    4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)

    5. Participation in another clinical trial within the last four weeks prior to study inclusion

    6. Former or present mental illnesses such as severe depression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder

    7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)

    8. Body temperature ≥ 38°C

    9. Present cardiovascular, respiratory, diabetic, or cancer disease

    10. Hepatitis A, B, C or other liver and renal disease

    11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial

    12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)

    13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phase I Unit of CannaXan GmbH Warngau Bavaria Germany 83627

    Sponsors and Collaborators

    • CannaXan GmbH

    Investigators

    • Principal Investigator: Stefan Lorenzl, Prof. Dr., Phase I Unit of CannaXan GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CannaXan GmbH
    ClinicalTrials.gov Identifier:
    NCT05267769
    Other Study ID Numbers:
    • SELECT 2
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CannaXan GmbH

    Study Results

    No Results Posted as of Jul 27, 2022