HealthyPhase 1NCT04930796
Food Effect Study of VER-01 in Healthy Volunteers
A Phase 1 study testing VER-01 in people with Healthy, run by Vertanical GmbH at 1 site in Austria.
Trial summary
Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VER-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 10 Aug 2022to 24 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
University of Medicine in Vienna - Department of Clinical Pharmacology
Vienna, 1090
About this study
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
Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers
Read the 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.
- Conditions
- Healthy
- Being tested
- VER-01
- Keywords
- THC, Tetrahydrocannabinol, Cannabis, Pharmacokinetics
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VER-01Drug
standardised cannabis extract (containing 21 mg THC per gram drug product)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: VER-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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-∞
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 max
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.
Measured: 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 L/F
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.
Measured: 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] - 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 in dependance of a high-fat meal.
Measured: On Day 1 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start10 Aug 2022
- Primary completion17 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertanical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Wolzt, Professor, Principal investigator, University of Medicine in Vienna - Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930796
- Sponsor's protocol ID
- VER-PK-002
- Status last verified
- Nov 2022
- First submitted
- 7 Jun 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04930796
- Acronym / sponsor ID
- VER-PK-002
- Conditions
- Healthy
- Keywords
- THC, Tetrahydrocannabinol, Cannabis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vertanical GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VER-01 following overnight fast (Day 1) and a high-fat breakfast (Day 4) | Experimental | Drug: VER-01The 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). |
| VER-01 following a high-fat breakfast (Day 1) and overnight fast (Day 4) | Experimental | Drug: VER-01The 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VER-01standardised cannabis extract (containing 21 mg THC per gram drug product) | Drug | 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) |
Primary outcome
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t
Time frame: 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-∞
Time frame: 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
Time frame: 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.
8 secondary outcomes
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
Time frame: 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-∞
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 max
Time frame: 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 L/F
Time frame: 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] - V area/F
Time frame: On Day 1 and Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, Professor principal investigator
University of Medicine in Vienna - Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VER-01 in people with Healthy, run by Vertanical GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t (time frame: On Day 1 and Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.