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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930809
• Other study ID #: VER-PK-001
• Status: Completed
• Phase: Phase 1
• Start date: November 25, 2021
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2022
• Source: Vertanical GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 11, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• VER-01
standardised cannabis extract (containing 21 mg THC per gram drug product)

Locations

Country	Name	City	State
Austria	University of Medicine in Vienna - Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vertanical GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC] - AUC 0-t	Analysis of the AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time.	Group A-D: Day 1; Group E-G: Day 1 and 4
Primary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC] - AUC 0-8	Analysis of AUC 0-8 (AUC from time 0 extrapolated to infinity) of THC over a defined period of time.	Group A-D: Day 1; Group E-G: Day 1 and 4
Primary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC] - C max	Analysis of C max (maximum plasma concentration) of THC over a defined period of time.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-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.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-tetrahydrocannabinol [THC-COOH] - AUC 0-8	Analysis of AUC 0-8 (AUC from time 0 extrapolated to infinity) of 11-OH-THC and THC-COOH over a defined period of time.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-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.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-tetrahydrocannabinol [THC-COOH] - ? z	Analysis of ? z (terminal elimination constant) of THC, 11-OH-THC and THC-COOH over a defined period of time.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-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.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-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.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-tetrahydrocannabinol [THC-COOH] - C L/F	Analysis of C L/F (plasma clearance) the pharmacokinetic profile of THC, 11-OH-THC and THC-COOH over a defined period of time.	Group A-D: Day 1; Group E-G: Day 1 and 4
Secondary	Pharmacokinetic profile of ?9-tetrahydrocannabinol [THC], 11-Hydroxy-?9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-?9-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.	Group A-D: Day 1; Group E-G: Day 1 and 4