Clinical Trial on Pharmacokinetic and Tolerability of AP701

March 9, 2021 updated by: CannaXan GmbH
This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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

    • Bavaria
      • Warngau, Bavaria, Germany, D-83627
        • Phase I Unit of CannaXan GmbH

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

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Male in the age of 35 - 60 year at study start
  3. Body mass index of 18 to 30 kg/m2
  4. Non-smoker, no use of any Tabaco products
  5. Good general health status (Karnofsky Score = 100)
  6. Current ECG without abnormal findings (i.a. 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 values for renal function (S-Creatinine, eGFR) 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, alcohol, 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. Present, former, or family history of mental illnesses such as severe de pression, 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 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)

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verum
AP701 single dose oromucosal application
Preparation of Cannabis flowers (Cannabis flos)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pharmacokinetic parameter of THC (area under the curve)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)
Time Frame: 24 hours
Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product
24 hours
Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)
Time Frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)
Time Frame: 24 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product
24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)
Time Frame: 30 hours
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
30 hours
Adverse events (AE)
Time Frame: 30 hours
Number and severity of adverse events (AE)
30 hours
Pschotropic drug effects measured by questionnaire
Time Frame: 30 hours
Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale
30 hours

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Stefan Lorenzl, PhD, Phase I Unit of CannaXan GmbH

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)

January 11, 2020

Primary Completion (Actual)

March 7, 2021

Study Completion (Actual)

March 7, 2021

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SELECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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