Food Effect Study of VER-01 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: VER-01

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • University of Medicine in Vienna - Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VER-01 following overnight fast (Day 1) and a high-fat breakfast (Day 4); 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).	Drug: VER-01; standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: VER-01 following a high-fat breakfast (Day 1) and overnight fast (Day 4); 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).	Drug: VER-01; standardised cannabis extract (containing 21 mg THC per gram drug product)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t	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.	On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞	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.	On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max	Analysis of C max (maximum plasma concentration) of THC over a defined period of time in dependance of a high-fat meal.	On Day 1 and Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞	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.	On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max	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.	On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z	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.	On Day 1 and Day 4
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	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.	On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max	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.	On Day 1 and Day 4
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	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.	On Day 1 and Day 4
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	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.	On Day 1 and Day 4

Collaborators and Investigators

• Sponsor: Vertanical GmbH
• Investigators: Principal Investigator: Michael Wolzt, Professor, University of Medicine in Vienna - Department of Clinical Pharmacology

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 24, 2022

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Cannabis; THC; Tetrahydrocannabinol
• Other Study ID Numbers: VER-PK-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No