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

Sponsor

Vertanical GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT04930809

Collaborator

(none)

Enrollment

Location

Arms

7.5

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: VER-01	Phase 1

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01after Single and Multiple Administration of Different Doses to Healthy Volunteers

Actual Study Start Date :

Nov 25, 2021

Actual Primary Completion Date :

Jul 4, 2022

Actual Study Completion Date :

Jul 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)
Experimental: 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).	Drug: VER-01 standardised cannabis extract (containing 21 mg THC per gram drug product)

Outcome Measures

Primary Outcome Measures

Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of the AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞ [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity) of THC over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of C max (maximum plasma concentration) of THC over a defined period of time.

Secondary Outcome Measures

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 [Group A-D: Day 1; Group E-G: Day 1 and 4]
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.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞ [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity) of 11-OH-THC and THC-COOH over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of C max (maximum plasma concentration) of 11-OH-THC and THC-COOH over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of λ z (terminal elimination constant) of THC, 11-OH-THC and THC-COOH over a defined period of time.
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 [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of t 1/2 (elimination half-life) of THC, 11-OH-THC and THC-COOH over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of T max (time to reach Cmax) of THC, 11-OH-THC and THC-COOH over a defined period of time.
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 [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of C L/F (plasma clearance) the pharmacokinetic profile of THC, 11-OH-THC and THC-COOH over a defined period of time.
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 [Group A-D: Day 1; Group E-G: Day 1 and 4]
Analysis of V area/F (volume of distribution) of THC, 11-OH-THC and THC-COOH over a defined period of time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Medicine in Vienna - Department of Clinical Pharmacology	Vienna		Austria	1090

Sponsors and Collaborators

Vertanical GmbH

Investigators

Principal Investigator: Michael Wolzt, Professor, University of Medicine in Vienna - Department of Clinical Pharmacology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vertanical GmbH

ClinicalTrials.gov Identifier:

NCT04930809

Other Study ID Numbers:

VER-PK-001

First Posted:

Jun 18, 2021

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vertanical GmbH

Study Results

No Results Posted as of Jul 14, 2022