Food Effect Study of VER-01 in Healthy Volunteers

NCT ID: NCT04930796

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2022-11-24

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

standardised cannabis extract (containing 21 mg THC per gram drug product)

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).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

standardised cannabis extract (containing 21 mg THC per gram drug product)

Interventions

VER-01

standardised cannabis extract (containing 21 mg THC per gram drug product)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vertanical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Wolzt, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Medicine in Vienna - Department of Clinical Pharmacology

Locations

University of Medicine in Vienna - Department of Clinical Pharmacology

Vienna, , Austria

Countries

Austria

Other Identifiers

VER-PK-002

Identifier Type: -

Identifier Source: org_study_id