Food Effect Study of VER-01 in Healthy Volunteers
- Registration Number
- NCT04930796
- Lead Sponsor
- Vertanical GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VER-01 following overnight fast (Day 1) and a high-fat breakfast (Day 4) VER-01 The PK profile of VER-01 is investigated after oral intake of a single dose 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 1). VER-01 following a high-fat breakfast (Day 1) and overnight fast (Day 4) VER-01 The PK profile of VER-01 is investigated after oral intake of a single dose VER-01 (corresponding to 10 mg THC) in the morning 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 (Group 2).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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] - 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] - 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] - 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] - 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] - 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 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.
Trial Locations
- Locations (1)
University of Medicine in Vienna - Department of Clinical Pharmacology
🇦🇹Vienna, Austria