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

Vertanical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: VER-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04930809

VER-PK-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 7 patient groups

VER-01 single dose (2.5 mg THC)

Experimental group

Description:

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

Treatment:

Drug: VER-01

VER-01 single dose (5 mg THC)

Experimental group

Description:

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

Treatment:

Drug: VER-01

VER-01 single dose (10 mg THC)

Experimental group

Description:

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

Treatment:

Drug: VER-01

VER-01 single dose (20 mg THC)

Experimental group

Description:

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

Treatment:

Drug: VER-01

VER-01 multiple dose (5 mg THC)

Experimental group

Description:

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).

Treatment:

Drug: VER-01

VER-01 multiple dose (10 mg THC)

Experimental group

Description:

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).

Treatment:

Drug: VER-01

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

Experimental group

Description:

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).

Treatment:

Drug: VER-01