Clinical trial NCT04930796: Food Effect Study of VER-01 in Healthy Volunteers
Official title: Randomized Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01 After Single Dose With and Without Meal in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: THC
Tetrahydrocannabinol
Cannabis
Pharmacokinetics
Lead sponsor: Vertanical GmbH
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t
timeFrame: On Day 1 and Day 4
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞
timeFrame: On Day 1 and Day 4
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max
timeFrame: On Day 1 and Day 4
Secondary outcomes:
measure: 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
timeFrame: On Day 1 and Day 4
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞
timeFrame: On Day 1 and Day 4
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max
timeFrame: On Day 1 and Day 4
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z
timeFrame: On Day 1 and Day 4
measure: 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
timeFrame: On Day 1 and Day 4
measure: Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max
timeFrame: On Day 1 and Day 4
measure: 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
timeFrame: On Day 1 and Day 4
measure: 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
timeFrame: On Day 1 and Day 4
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Medicine in Vienna - Department of Clinical Pharmacology
Study officials:
affiliation: University of Medicine in Vienna - Department of Clinical Pharmacology
name: Michael Wolzt, Professor
role: PRINCIPAL_INVESTIGATOR
References: