Pharmacokinetics, BioavailabilityPhase 1NCT03471559
Cannabidiol - an in Vivo Innovative Drug Delivery Study
A Phase 1 study testing Cannabidiol in people with Pharmacokinetics, Bioavailability, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Bioavailability
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 10 Dec 2018to 29 Aug 2019
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent given by the subject
- Negative drug screening at the time of screening
- Non-smoking
- In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than 1.
- Body Mass Index between 18.5 kg/m2 and 30 kg/m2
Who cannot join
- Lack of accountability
- Pregnancy or lactation phase in females at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)
- Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)
- Consumption of any illicit drugs (except cannabis in history, see above)
- Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematologic or endocrinologic disorders or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, as assessed by the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department I of Pharmacology, University of Cologne
Cologne, 50931
About this study
Official title: Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.
Read the detailed description
This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulation) with an intranasal cannabidiol gel (test formulation), with the further aim to find an appropriate dosing of the new pharmaceutical preparation. The intranasal administration may also be suitable to reduce the high variability in the bioavailability of cannabidiol observed for the current oral administration.
- Conditions
- Pharmacokinetics, Bioavailability
- Being tested
- Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
single or multiple dosing
| Study group | Role | What they receive |
|---|---|---|
| Reference formulation | Active comparator | Cannabidiol capsule, 200 mg Receives: Drug: Cannabidiol |
| New formulation | Experimental | Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study) Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞))
reference formulation compared to new formulation
Measured: 36 hours
Pharmacokinetic profile of single dose - residual area
reference formulation compared to new formulation
Measured: 36 hours
Pharmacokinetic profile of single dose - maximum concentration (Cmax)
reference formulation compared to new formulation
Measured: 36 hours
Pharmacokinetic profile of single dose - time to reach Cmax (tmax)
reference formulation compared to new formulation
Measured: 36 hours
Pharmacokinetic profile of single dose - elimination half life (t1/2)
reference formulation compared to new formulation
Measured: 36 hours
Pharmacokinetic profile of single dose - elimination rate constant (λz)
reference formulation compared to new formulation
Measured: 36 hours
Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ))
reference formulation compared to new formulation
Measured: 9 days
Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss)
reference formulation compared to new formulation
Measured: 9 days
Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss)
reference formulation compared to new formulation
Measured: 9 days
Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h))
reference formulation compared to new formulation
Measured: 9 days
Pharmacokinetic profile of multiple dosing - steady state accumulation ratio
reference formulation compared to new formulation
Measured: 9 days
Secondary outcomes (5)
Regular laboratory testing
standard laboratory blood tests
Measured: 36h or 9 days
Electrocardiography - QTc time
Measured: 36 hours or 9 days
Vital signs - body temperature
Measured: 36 hours or 9 days
Vital signs - blood pressure
Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg)
Measured: 36 hours or 9 days
Vital signs - pulse rate
Measured: 36 hours or 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start10 Dec 2018
- Primary completion30 Jun 2019
- Study completion29 Aug 2019
Why it stopped: Two step study, step two was not feasible based on results from phase one.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics, BioavailabilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uwe Fuhr, MD, Principal investigator, Department I of Pharmacology, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471559
- Sponsor's protocol ID
- CBD-DDS
- Status last verified
- Jun 2020
- First submitted
- 7 Mar 2018
- Last updated
- 1 Jul 2020
- 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 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
- ClinicalTrials.gov ID
- NCT03471559
- Acronym / sponsor ID
- CBD-DDS
- Conditions
- Pharmacokinetics, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Two step study, step two was not feasible based on results from phase one.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 20 Mar 2018 (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.
Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.
Detailed description
This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulation) with an intranasal cannabidiol gel (test formulation), with the further aim to find an appropriate dosing of the new pharmaceutical preparation. The intranasal administration may also be suitable to reduce the high variability in the bioavailability of cannabidiol observed for the current oral administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference formulation | Active comparator | Drug: CannabidiolCannabidiol capsule, 200 mg |
| New formulation | Experimental | Drug: CannabidiolCannabidiol, intranasal gel (XX mg, dose need to be determined during the study) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent given by the subject
- Negative drug screening at the time of screening
- Non-smoking
- In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than 1.
- Body Mass Index between 18.5 kg/m2 and 30 kg/m2
Key exclusion criteria (7 listed)
- Lack of accountability
- Pregnancy or lactation phase in females at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)
- Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)
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 |
|---|---|---|
| Cannabidiolsingle or multiple dosing | Drug | New formulation, Reference formulation |
Primary outcome
Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞))
Time frame: 36 hours
reference formulation compared to new formulation
Pharmacokinetic profile of single dose - residual area
Time frame: 36 hours
reference formulation compared to new formulation
Pharmacokinetic profile of single dose - maximum concentration (Cmax)
Time frame: 36 hours
reference formulation compared to new formulation
Pharmacokinetic profile of single dose - time to reach Cmax (tmax)
Time frame: 36 hours
reference formulation compared to new formulation
Pharmacokinetic profile of single dose - elimination half life (t1/2)
Time frame: 36 hours
reference formulation compared to new formulation
Pharmacokinetic profile of single dose - elimination rate constant (λz)
Time frame: 36 hours
reference formulation compared to new formulation
Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ))
Time frame: 9 days
reference formulation compared to new formulation
Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss)
Time frame: 9 days
reference formulation compared to new formulation
Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss)
Time frame: 9 days
reference formulation compared to new formulation
Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h))
Time frame: 9 days
reference formulation compared to new formulation
Pharmacokinetic profile of multiple dosing - steady state accumulation ratio
Time frame: 9 days
reference formulation compared to new formulation
5 secondary outcomes
Regular laboratory testing
Time frame: 36h or 9 days
Electrocardiography - QTc time
Time frame: 36 hours or 9 days
Vital signs - body temperature
Time frame: 36 hours or 9 days
Vital signs - blood pressure
Time frame: 36 hours or 9 days
Vital signs - pulse rate
Time frame: 36 hours or 9 days
Results and safety
The study was stopped early (reason given: Two step study, step two was not feasible based on results from phase one.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- 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.
Uwe Fuhr, MD principal investigator
Department I of Pharmacology, University of Cologne
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 Cannabidiol in people with Pharmacokinetics, Bioavailability, run by Central Institute of Mental Health, Mannheim 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Jul 2020. 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 was stopped early (reason given: Two step study, step two was not feasible based on results from phase one.). Results are not available in the source record.
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 single dose - area under the curve (AUC(0-t)), AUC(0-∞)) (time frame: 36 hours). The study lists 11 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 1 Jul 2020.