Food Effect Study of VER-01 in Healthy Volunteers

NCT04930796 | Completed Phase 1 DMC

• 1 other identifier: VER-PK-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

THC; Tetrahydrocannabinol; Cannabis; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t

  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.

  On Day 1 and Day 4

• Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞

  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.

  On Day 1 and Day 4

• Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max

  Analysis of C max (maximum plasma concentration) of THC over a defined period of time in dependance of a high-fat meal.

  On Day 1 and Day 4

Secondary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

VER-01 following overnight fast (Day 1) and a high-fat breakfast (Day 4)

EXPERIMENTAL

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

VER-01 following a high-fat breakfast (Day 1) and overnight fast (Day 4)

EXPERIMENTAL

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

Interventions

VER-01 DRUG

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

VER-01 following a high-fat breakfast (Day 1) and overnight fast (Day 4); VER-01 following overnight fast (Day 1) and a high-fat breakfast (Day 4)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertanical GmbH: lead

Study Sites (1)

University of Medicine in Vienna - Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Wolzt, Professor

  University of Medicine in Vienna - Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: August 10, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 24, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)