Clinical Trial on Pharmacokinetic and Tolerability of AP701

Study Overview
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Brief Summary
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This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Detailed Description
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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.

Official Title
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Clinical Trial on Pharmacokinetic and Tolerability of AP701

Conditions
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Pharmacokinetic, Tolerability, Safety

Intervention / Treatment
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* Drug: AP701


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>AP701 single dose oromucosal application | Drug: AP701<br>* Preparation of Cannabis flowers (Cannabis flos)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetic parameter of THC (area under the curve) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product | 30 hours | 
| Adverse events (AE) | Number and severity of adverse events (AE) | 30 hours | 
| Pschotropic drug effects measured by questionnaire | Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale | 30 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis, Cannabis based medicine, THC, Tetrahydrocannbinol