PharmacokineticPhase 1NCT04708795
Clinical Trial on Pharmacokinetic and Tolerability of AP701
A Phase 1 study testing AP701 in people with Pharmacokinetic and Tolerability, run by CannaXan GmbH at 1 site in Germany.
Trial summary
This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 35 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic, Tolerability, Safety
- What is being tested?
- AP701
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2020to 7 Mar 2021
- 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 35 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated informed consent form
- Male in the age of 35 - 60 year at study start
- Body mass index of 18 to 30 kg/m2
- Non-smoker, no use of any Tabaco products
- Good general health status (Karnofsky Score = 100)
- Current ECG without abnormal findings (i.a. QTcF < 450 ms)
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- Physical examination, medical history without exclusionary findings
- Pulse rate between 50 and 90 bpm
- Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
- Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
- Lab values for renal function (S-Creatinine, eGFR) within normal range
- Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
- Negative test result of urine screening for Cannabis, alcohol, and substance abuse
Who cannot join
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Use of Cannabis products within the last 8 weeks
- Use of opioids
- Former or present dependency (e.g. to alcohol, medicinal products, drugs)
- Participation in another clinical trial within the last four weeks prior to study inclusion
- Present, former, or family history of mental illnesses such as severe de pression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
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- Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
- Body temperature ≥ 38 °C
- Present cardiovascular, respiratory, diabetic, or cancer disease
- Hepatitis or other liver and renal disease
- Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
- Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
- Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.
Read the detailed description
Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.
- Conditions
- Pharmacokinetic, Tolerability, Safety
- Being tested
- AP701
- Keywords
- Cannabis, Cannabis based medicine, THC, Tetrahydrocannbinol
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP701Drug
Preparation of Cannabis flowers (Cannabis flos)
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | AP701 single dose oromucosal application Receives: Drug: AP701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pharmacokinetic parameter of THC (area under the curve)
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Secondary outcomes (15)
Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)
Pharmacokinetic outcome of THC measured 0 to detection limits after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)
Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product
Measured: 24 hours
Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 24 hours after application of investigational product
Measured: 24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)
Pharmacokinetic outcome of 11-OH-THC measured 0 to 30 hours after application of investigational product
Measured: 30 hours
Adverse events (AE)
Number and severity of adverse events (AE)
Measured: 30 hours
Pschotropic drug effects measured by questionnaire
Questionnaire comprising 17 questions on intoxication to be answered on numeric rating scale
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start11 Jan 2020
- Primary completion7 Mar 2021
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CannaXan GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Lorenzl, PhD, Principal investigator, Phase I Unit of CannaXan GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708795
- Sponsor's protocol ID
- SELECT
- Status last verified
- Mar 2021
- First submitted
- 21 Dec 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Pharmacokinetic and Tolerability of AP701
- ClinicalTrials.gov ID
- NCT04708795
- Acronym / sponsor ID
- SELECT
- Conditions
- Pharmacokinetic, Tolerability, Safety
- Keywords
- Cannabis, Cannabis based medicine, THC, Tetrahydrocannbinol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CannaXan GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 14 Jan 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.
This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.
Detailed description
Pharmacokinetic parameters and tolerability of AP701 is studied over 30 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: AP701AP701 single dose oromucosal application |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Signed and dated informed consent form
- Male in the age of 35 - 60 year at study start
- Body mass index of 18 to 30 kg/m2
- Non-smoker, no use of any Tabaco products
- Good general health status (Karnofsky Score = 100)
Key exclusion criteria (13 listed)
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Use of Cannabis products within the last 8 weeks
- Use of opioids
- Former or present dependency (e.g. to alcohol, medicinal products, drugs)
- Participation in another clinical trial within the last four weeks prior to study inclusion
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 |
|---|---|---|
| AP701Preparation of Cannabis flowers (Cannabis flos) | Drug | Verum |
Primary outcome
Evaluation of pharmacokinetic parameter of THC (area under the curve)
Time frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)
Time frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)
Time frame: 30 hours
Pharmacokinetic outcome of THC measured 0 to 30 hours after application of investigational product
15 secondary outcomes
Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)
Time frame: 24 hours
Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)
Time frame: 24 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)
Time frame: 30 hours
Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)
Time frame: 30 hours
Adverse events (AE)
Time frame: 30 hours
Pschotropic drug effects measured by questionnaire
Time frame: 30 hours
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 10 Mar 2021.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
Stefan Lorenzl, PhD principal investigator
Phase I Unit of CannaXan GmbH
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 AP701 in people with Pharmacokinetic and Tolerability, run by CannaXan GmbH at 1 site in Germany.
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 13 inclusion and 13 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 10 Mar 2021. 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 Germany. 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?
Evaluation of pharmacokinetic parameter of THC (area under the curve) (time frame: 30 hours). 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 10 Mar 2021.