food effect study of ver-01 in healthy volunteers

Conditions: Healthy

Summary: evaluation of pharmacokinetics, tolerability and safety of ver-01 depending on the intake a high-fat meal in healthy volunteers

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.

Eligibility criteria:
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.

Keywords: thc tetrahydrocannabinol cannabis pharmacokinetics