Randomized Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01 After Single Dose With and Without Meal in Healthy Volunteers

VER-PK-002

Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers

2022-08-10

2022-11-17

2022-11-24

Completed

Early phase I

18

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2022-11-28