Healthy
Conditions
Keywords
THC, Tetrahydrocannabinol, Cannabis, Pharmacokinetics
Brief summary
Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers
Detailed description
Determination of the effect of food intake on the pharmacokinetic (PK) profile of VER-01 in healthy volunteers. Group 1: 9 subjects receive VER-01 (corresponding to 10 mg THC) in the morning after a 10-hour fasting period on day 1, and 30 minutes after the intake of a standardised high-fat breakfast has been started on day 4. Group 2: 9 subjects receive VER-01 (corresponding to 10 mg THC) in the morning after 30 minutes after the intake of a standardised high-fat breakfast has been started on day 1 and after a 10-hour fasting period on day 4.
Interventions
DRUGVER-01
standardised cannabis extract (containing 21 mg THC per gram drug product)
Sponsors
Vertanical GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male volunteers * Age: 18-45 years * BMI: 19-30 kg/m² * Body weight ≥ 50 kg * volunteers in good general condition based on medical history, physical examination, resting ECG and clinical laboratory tests * Willingness of men to use a reliable method of contraception and not to donate sperm during and at least 3 months after the last intake of the study product * Understanding of the German language, ability to give consent and compliance * The subject has understood the instructions to avoid changes in lifestyle and eating habits * Signed patient information and consent form of the study participant * Study participant can stick to the diet plan, especially high-fat breakfast
Exclusion criteria
* Consumption of cannabis-based products within 30 days prior to study start * Well-known strong adverse events in connection with cannabis consumption * Known allergy to cannabis, sesame seeds, or derivative products * alcohol/drug/medication abuse or physical dependence on opioids, barbiturates, amphetamines, cocaine or benzodiazepines within the last 10 years or current intake of methadone * Positive drug test for illegal substances and/or alcohol test at time T0 * Heavy smokers (\>10 cigarettes/day) * Heavy caffeine consumers (\>450 mg caffeine/day equal to approx. 5-6 cups of filter coffee) * Drastic change in diet within 30 days before study start * Mental illness (psychoses, schizophrenia, bipolar disorder, severe depression, anxiety disorder, suicide) * Mental illness (psychoses, schizophrenia, bipolar disorder, severe depression, anxiety disorder, suicide) in a first-degree relative (parents and children) * subjects with orthostatic hypotension during screening (drop in systolic blood pressure by ≥20 mmHg after change of position) * Cardiovascular event within the last 3 months, untreated hypertension, untreated hypothyroidism, surgery within the last 2 months * cardiac insufficiency * Subjects with a serious disease or disorder which, in the opinion of the investigator, does not allow safe participation in the study from a medical point of view * Intake of prescription drugs within the last 14 days, OTC test products within the last 7 days before the start of the study or during the study period * Eating of grapefruit products is not allowed during the study and 10 days before the first intake of the study product * Participation in another clinical trial in the period of 90 days before the start of the trial * Existing desire to have children or planned sperm donation (within the duration of the study and 3 months after end of the study) * Planned blood donation * No ability to consent * Subject is in a dependency/employment relationship with the sponsor or investigator or other persons who may be under pressure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t | On Day 1 and Day 4 | Analysis of AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞ | On Day 1 and Day 4 | Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity) of THC over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max | On Day 1 and Day 4 | Analysis of C max (maximum plasma concentration) of THC over a defined period of time in dependance of a high-fat meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z | On Day 1 and Day 4 | Analysis of λ z (terminal elimination constant) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - t 1/2 | On Day 1 and Day 4 | Analysis of t 1/2 (elimination half-life) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-t | On Day 1 and Day 4 | Analysis of AUC 0-t (AUC from time 0 to 24 hours) of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C L/F | On Day 1 and Day 4 | Analysis of C L/F (plasma clearance) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - V area/F | On Day 1 and Day 4 | Analysis of V area/F (volume of distribution) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max | On Day 1 and Day 4 | Analysis of T max (time to reach Cmax)of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞ | On Day 1 and Day 4 | Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity)of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
| Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max | On Day 1 and Day 4 | Analysis of C max (maximum plasma concentration) of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal. |
Countries
Austria
Outcome results
None listed