- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04708795
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
Conditions
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:
- Signed and dated informed consent form
- Male in the age of 35 - 60 year at study start
- Body mass index of 18 to 30 kg/m2
- Non-smoker, no use of any Tabaco products
- Good general health status (Karnofsky Score = 100)
- Current ECG without abnormal findings (i.a. QTcF < 450 ms)
- Physical examination, medical history without exclusionary findings
- Pulse rate between 50 and 90 bpm
- Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
- Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
- Lab values for renal function (S-Creatinine, eGFR) within normal range
- Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
- Negative test result of urine screening for Cannabis, alcohol, and substance abuse
Exclusion Criteria:
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Use of Cannabis products within the last 8 weeks
- Use of opioids
- Former or present dependency (e.g. to alcohol, medicinal products, drugs)
- Participation in another clinical trial within the last four weeks prior to study inclusion
- Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
- Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
- Body temperature ≥ 38 °C
- Present cardiovascular, respiratory, diabetic, or cancer disease
- Hepatitis or other liver and renal disease
- 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
- Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
- 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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