Single and Multiple Dose Study of VER-01 in Healthy Volunteers

NCT ID: NCT04930809

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2022-07-11

Brief Summary

Evaluation of pharmacokinetics, tolerability and safety of VER-01 in healthy volunteers

Detailed Description

Determination of the single and multiple dose pharmacokinetic profile of VER-01 in healthy volunteers.

Single dose: 6 subjects each will receive VER-01 corresponding to 2.5 mg (Group A), 5 mg (Group B), 10 mg (Group C) or 20 mg THC (Group D) in the morning.

Multiple dose: 6 Subjects each receive VER-01 corresponding to 5 mg (Group E) or 10 mg (Group F) THC in the morning and in the evening on 4 consecutive days. A third group (Group G) receives VER-01 corresponding to 12.5 mg THC in the morning and 20 mg THC in the evening on 4 consecutive days.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VER-01 single dose (2.5 mg THC)

PK profile is investigated after oral intake of a single dose VER-01 corresponding to 2.5 mg THC (Group A).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

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

VER-01 single dose (5 mg THC)

PK profile is investigated after oral intake of a single dose VER-01 corresponding to 5 mg THC (Group B).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

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

VER-01 single dose (10 mg THC)

PK profile is investigated after oral intake of a single dose VER-01 corresponding to 10 mg THC (Group C).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

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

VER-01 single dose (20 mg THC)

PK profile is investigated after oral intake of a single dose VER-01 corresponding to 20 mg THC (Group D).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

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

VER-01 multiple dose (5 mg THC)

PK profile is investigated after oral intake of VER-01 corresponding to 5 mg THC in the morning and 5 mg THC in the evening on 4 consecutive days (Group E).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

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

VER-01 multiple dose (10 mg THC)

PK profile is investigated after oral intake of VER-01 corresponding to 10 mg THC in the morning and 10 mg THC in the evening on 4 consecutive days (Group F).

Group Type: EXPERIMENTAL

VER-01

Intervention Type: DRUG

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

VER-01 multiple dose (12.5 / 20 mg THC)

PK profile is investigated after oral intake of VER-01 corresponding to 12.5 mg THC in the morning and 20.5 mg THC in the evening on 4 consecutive days (Group F).

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 written informed consent form of the study participant

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, over-the-counter 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-001

Identifier Type: -

Identifier Source: org_study_id