Food Effect Study of VER-01 in Healthy Volunteers

Sponsor

Vertanical GmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04930796

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01 After Single Dose With and Without Meal in Healthy Volunteers

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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).

Drug: VER-01

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

Experimental: 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).

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 [On Day 1 and Day 4]
Analysis of AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time in dependance of a high-fat meal.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞ [On Day 1 and Day 4]
Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity) of THC over a defined period of time in dependance of a high-fat meal.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max [On Day 1 and Day 4]
Analysis of C max (maximum plasma concentration) of THC over a defined period of time in dependance of a high-fat meal.

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 [On Day 1 and Day 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 in dependance of a high-fat meal.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞ [On Day 1 and Day 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 in dependance of a high-fat meal.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max [On Day 1 and Day 4]
Analysis of C max (maximum plasma concentration) of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z [On Day 1 and Day 4]
Analysis of λ z (terminal elimination constant) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
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 [On Day 1 and Day 4]
Analysis of t 1/2 (elimination half-life) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max [On Day 1 and Day 4]
Analysis of T max (time to reach Cmax)of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
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 [On Day 1 and Day 4]
Analysis of C L/F (plasma clearance) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
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 [On Day 1 and Day 4]
Analysis of V area/F (volume of distribution) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.

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 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.

Contacts and Locations

Locations

No locations specified.

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:

NCT04930796

Other Study ID Numbers:

VER-PK-002

First Posted:

Jun 18, 2021

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

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 Nov 26, 2021