Pharmacokinetic, Safety, Tolerability
Conditions
Keywords
Cannabis, Cannabis based medicine, THC, Tetrahydrocannbinol
Brief summary
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
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.
Interventions
DRUGAP701
Preparation of Cannabis flowers (Cannabis flos)
Sponsors
CannaXan GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pharmacokinetic parameter of THC (area under the curve) | 30 hours | Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration) | 30 hours | Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration) | 30 hours | Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits) | 30 hours | Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope) | 30 hours | Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits) | 30 hours | Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope) | 30 hours | Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product |
| Adverse events (AE) | 30 hours | Number and severity of adverse events (AE) |
| Pschotropic drug effects measured by questionnaire | 30 hours | Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale |
| 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 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) | 30 hours | Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product |
Countries
Germany
Outcome results
None listed