HealthyPhase 1NCT04930809
Single and Multiple Dose 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 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
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 25 Nov 2021to 11 Jul 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 written informed consent form of the study participant
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, 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.
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: Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01after Single and Multiple Administration of Different Doses to Healthy Volunteers
Evaluation of pharmacokinetics, tolerability and safety of VER-01 in healthy volunteers
Read the 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 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.
- 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 single dose (2.5 mg THC) | Experimental | PK profile is investigated after oral intake of a single dose VER-01 corresponding to 2.5 mg THC (Group A). Receives: Drug: VER-01 |
| VER-01 single dose (5 mg THC) | Experimental | PK profile is investigated after oral intake of a single dose VER-01 corresponding to 5 mg THC (Group B). Receives: Drug: VER-01 |
| VER-01 single dose (10 mg THC) | Experimental | PK profile is investigated after oral intake of a single dose VER-01 corresponding to 10 mg THC (Group C). Receives: Drug: VER-01 |
| VER-01 single dose (20 mg THC) | Experimental | PK profile is investigated after oral intake of a single dose VER-01 corresponding to 20 mg THC (Group D). Receives: Drug: VER-01 |
| VER-01 multiple dose (5 mg THC) | Experimental | 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). Receives: Drug: VER-01 |
| VER-01 multiple dose (10 mg THC) | Experimental | 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). Receives: Drug: VER-01 |
| VER-01 multiple dose (12.5 / 20 mg THC) | Experimental | 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). 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 the AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max
Analysis of C max (maximum plasma concentration) of THC over a defined period of time.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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) the pharmacokinetic profile of THC, 11-OH-THC and THC-COOH over a defined period of time.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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.
Measured: Group A-D: Day 1; Group E-G: Day 1 and 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 start25 Nov 2021
- Primary completion4 Jul 2022
- Study completion11 Jul 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT04930809
- Sponsor's protocol ID
- VER-PK-001
- Status last verified
- Jul 2022
- First submitted
- 24 May 2021
- Last updated
- 14 Jul 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01after Single and Multiple Administration of Different Doses to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04930809
- Acronym / sponsor ID
- VER-PK-001
- Conditions
- Healthy
- Keywords
- THC, Tetrahydrocannabinol, Cannabis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vertanical GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 11 Jul 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 in healthy volunteers
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| VER-01 single dose (2.5 mg THC) | Experimental | Drug: VER-01PK profile is investigated after oral intake of a single dose VER-01 corresponding to 2.5 mg THC (Group A). |
| VER-01 single dose (5 mg THC) | Experimental | Drug: VER-01PK profile is investigated after oral intake of a single dose VER-01 corresponding to 5 mg THC (Group B). |
| VER-01 single dose (10 mg THC) | Experimental | Drug: VER-01PK profile is investigated after oral intake of a single dose VER-01 corresponding to 10 mg THC (Group C). |
| VER-01 single dose (20 mg THC) | Experimental | Drug: VER-01PK profile is investigated after oral intake of a single dose VER-01 corresponding to 20 mg THC (Group D). |
| VER-01 multiple dose (5 mg THC) | Experimental | Drug: VER-01PK 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). |
| VER-01 multiple dose (10 mg THC) | Experimental | Drug: VER-01PK 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). |
| VER-01 multiple dose (12.5 / 20 mg THC) | Experimental | Drug: VER-01PK 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 multiple dose (10 mg THC), VER-01 multiple dose (12.5 / 20 mg THC), VER-01 multiple dose (5 mg THC), VER-01 single dose (10 mg THC), VER-01 single dose (2.5 mg THC), VER-01 single dose (20 mg THC), VER-01 single dose (5 mg THC) |
Primary outcome
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t
Time frame: 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-∞
Time frame: 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
Time frame: 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.
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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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: Group A-D: Day 1; Group E-G: Day 1 and 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 14 Jul 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 9 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 14 Jul 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: Group A-D: Day 1; Group E-G: Day 1 and 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 14 Jul 2022.