Clinical Trial on Pharmacokinetics and Tolerability of AP707
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Verum AP707 single dose oromucosal application |
Drug: AP707
Preparation of Cannabis flowers (Cannabis flos)
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Adverse events (AE) [24 hours]
Number and severity of adverse events (AE)
- 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
Inclusion Criteria:
-
Signed and dated informed consent form
-
Male at the age of 30 - 60 years at study start
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Body mass index of 18 to 30 kg/m2
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Non-smoker, no use of any tobacco products,
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Good general health status (Karnofsky Score = 100; see Annex 1, page 59)
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Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (QTcF < 450 ms)
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Physical examination, medical history without exclusionary findings
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Pulse rate between 50 and 90 bpm
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Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
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Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
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Lab value for renal function (S-Creatinine, eGFR according to CKD-EPI) within normal range
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Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
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Negative test result of urine screening for Cannabis and substance abuse
Exclusion Criteria:
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Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
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Use of Cannabis products within the last 8 weeks
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Use of opioids
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Former or present dependency (e.g. to alcohol, medicinal products, drugs)
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Participation in another clinical trial within the last four weeks prior to study inclusion
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Former or present mental illnesses such as severe depression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
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Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
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Body temperature ≥ 38°C
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Present cardiovascular, respiratory, diabetic, or cancer disease
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Hepatitis A, B, C or other liver and renal disease
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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
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Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
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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.- SELECT 2