Comparative BioavailabilityPhase 1NCT04790136
Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration
A Phase 1 study testing GLA-015 and DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" in people with Comparative Bioavailability, run by SocraTec R&D GmbH at 1 site in Germany.
Trial summary
Glatt Pharmaceutical Services GmbH \& Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comparative Bioavailability
- What is being tested?
- GLA-015 and DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"
- 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 siteGermany
- Study dates
- 17 Mar 2021to 12 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ethnic origin: Caucasian
- age: 18 years or older (including)
- body-mass index (BMI): >= 18.5 kg/m² and <= 30.0 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 1 month
- written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
Who cannot join
- Safety concerns
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- hepatic impairment
Show all 38Show fewer
- history of bradycardia, tachycardia or other arrhythmic symptoms of clinical significance
- Nurses Global Assessment of Suicide Risk (NGASR)-scale showing a high or very high risk
- known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
- history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- systolic blood pressure < 90 or > 139 mmHg
- diastolic blood pressure < 60 or > 89 mmHg
- heart rate < 50 bpm or > 90 bpm
- QTc interval > 450 ms for men and > 470 ms for women
- ASAT > 20% ULN, ALAT > 10% ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 µmol/l ULN)
- all other laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
- diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the subject
- contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the subject
- known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the subject
- Lack of suitability for the clinical trial
- acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
- history of or current drug or alcohol dependence
- positive alcohol, cotinine or drug test at screening examination
- regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day
- subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
- regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
- blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
- administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
- regular treatment with any systemically available medication (except hormonal contraceptives and hormonal replacement therapy, e.g. estrogens, L-thyroxine)
- subjects, who report a frequent occurrence of migraine attacks
- For female subjects with childbearing potential only:
- positive pregnancy test at screening examination
- pregnant or lactating women
- female subjects who do not agree to apply highly effective contraceptive methods
- Administrative reasons
- subjects suspected or known not to follow instructions
- subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
SocraTec R&D GmbH Clinical Pharmacology Unit
Erfurt, Thuringia, 99084
About this study
Official title: Characterisation of Relative Bioavailability of GLA-015 in Comparison With an Oily Cannabidiol Solution (NRF 22.10) - a Multiple Dose, Randomised, 2-period Crossover-trial With Twice Daily Administration in Healthy Adult Male and Female Subjects
Glatt Pharmaceutical Services GmbH \& Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions.
The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.
Read the detailed description
This single centre, open-label, randomised (order of treatments), balanced, multiple dose trial will be performed in a 2-period, 2-sequence-crossover design with direct switch-over. Eighteen (18) healthy subjects of both sexes (balanced distribution intended, but minimum 40% of each sex) are intended to be randomised.
The IMPs will be administered after a light meal as single oral doses of 1500 mg cannabidiol (i.e. 5.051 g granules of Test to be dispersed in water or 15 ml solution of Reference) twice daily (i.e. every 12 h) over 7 consecutive days.
Blood sampling will be performed after the 13th administration over 24 h, thereby including the 14th administration, in order to characterise pharmacokinetic parameters after multiple dosing over a whole day interval.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions by means of AUC144-168,ss, Cmax,144-168,ss, and Cmin,144-168,ss of CBD and 7-OH-CBD.
The clinical trial will be performed as a cross-over investigation with intra-individual comparison, thus reducing variability of the pharmacokinetic parameters, which is supposed to be higher between subjects than within an individual subject.
- Conditions
- Comparative Bioavailability
- Being tested
- GLA-015, DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"
- Keywords
- Bioavailability, Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA-015Drug
administration followed by PK blood sampling
DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"Drug
administration followed by PK blood sampling
| Study group | Role | What they receive |
|---|---|---|
| GLA-015 | Experimental | GLA-015 (Glatt Pharmaceutical Services GmbH \& Co. KG, Germany); 5.051 g granules containing 1500 mg cannabidiol to be dispersed in water; oral multiple dose administration twice daily over 7 consecutive days after a light meal Receives: Drug: GLA-015 |
| DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" | Active comparator | DAC C-052 "Cannabidiol" / NRF 22.10 "Ölige Cannabidiol-Lösung 100 mg/ml" ("Oily cannabidiol solution 100 mg/ml") (Glatt Pharmaceutical Services GmbH \& Co. KG, Germany; according to DAC/NRF specifications); 15 ml solution containing 1500 mg cannabidiol; oral multiple dose administration twice daily over 7 consecutive days after a light meal Receives: Drug: DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of cannabidiol
AUC144-168,ss = partial area under the concentration vs. time curve over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations)
Measured: 24 hours
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmax,144-168,ss of cannabidiol
Cmax,144-168,ss = observed maximum concentration over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Measured: 24 hours
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmin,144-168,ss of cannabidiol
Cmin,144-168,ss = (absolute) minimum concentrations over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Measured: 24 hours
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of 7-OH-CBD
AUC144-168,ss = partial area under the concentration vs. time curve over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations)
Measured: 24 hours
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmax,144-168,ss, of 7-OH-CBD
Cmax,144-168,ss = observed maximum concentration over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Measured: 24 hours
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmin,144-168,ss of 7-OH-CBD
Cmin,144-168,ss = (absolute) minimum concentrations over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Measured: 24 hours
Secondary outcomes (2)
Frequency of Adverse Events
Descriptive statistics with regard to frequency of adverse events considering intensity, relationship to the IMP, action taken, outcome, and seriousness as well as period and treatment
Measured: 14 days
Frequency of subjects showing Adverse Events
Descriptive statistics with regard to frequency of subjects showing adverse events considering intensity, relationship to the IMP, action taken, outcome, and seriousness as well as period and treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start17 Mar 2021
- Primary completion16 Apr 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- SocraTec R&D GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Glatt Pharmaceutical Services GmbH & Co. KG, SocraMetrics GmbH
- Responsible party
- Sponsor
- Investigators
- Frank Donath, Principal investigator, SocraTec R&D GmbH Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790136
- Sponsor's protocol ID
- 1393cbd20ct
- Other IDs
- 2020-004807-15
- Status last verified
- Jul 2021
- First submitted
- 3 Mar 2021
- Last updated
- 13 Jul 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Relative Bioavailability of GLA-015 in Comparison With an Oily Cannabidiol Solution (NRF 22.10) - a Multiple Dose, Randomised, 2-period Crossover-trial With Twice Daily Administration in Healthy Adult Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04790136
- Acronym / sponsor ID
- 1393cbd20ct
- Conditions
- Comparative Bioavailability
- Keywords
- Bioavailability, Cannabidiol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SocraTec R&D GmbHUniversity, hospital or other
- Collaborators
- Glatt Pharmaceutical Services GmbH & Co. KG, SocraMetrics GmbH
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 10 Mar 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.
Glatt Pharmaceutical Services GmbH \& Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions.
The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.
Detailed description
This single centre, open-label, randomised (order of treatments), balanced, multiple dose trial will be performed in a 2-period, 2-sequence-crossover design with direct switch-over. Eighteen (18) healthy subjects of both sexes (balanced distribution intended, but minimum 40% of each sex) are intended to be randomised.
The IMPs will be administered after a light meal as single oral doses of 1500 mg cannabidiol (i.e. 5.051 g granules of Test to be dispersed in water or 15 ml solution of Reference) twice daily (i.e. every 12 h) over 7 consecutive days.
Blood sampling will be performed after the 13th administration over 24 h, thereby including the 14th administration, in order to characterise pharmacokinetic parameters after multiple dosing over a whole day interval.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions by means of AUC144-168,ss, Cmax,144-168,ss, and Cmin,144-168,ss of CBD and 7-OH-CBD.
The clinical trial will be performed as a cross-over investigation with intra-individual comparison, thus reducing variability of the pharmacokinetic parameters, which is supposed to be higher between subjects than within an individual subject.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLA-015 | Experimental | Drug: GLA-015GLA-015 (Glatt Pharmaceutical Services GmbH \& Co. KG, Germany); 5.051 g granules containing 1500 mg cannabidiol to be dispersed in water; oral multiple dose administration twice daily over 7 consecutive days after a light meal |
| DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" | Active comparator | Drug: DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"DAC C-052 "Cannabidiol" / NRF 22.10 "Ölige Cannabidiol-Lösung 100 mg/ml" ("Oily cannabidiol solution 100 mg/ml") (Glatt Pharmaceutical Services GmbH \& Co. KG, Germany; according to DAC/NRF specifications); 15 ml solution containing 1500 mg cannabidiol; oral multiple dose administration twice daily over 7 consecutive days after a light meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ethnic origin: Caucasian
- age: 18 years or older (including)
- body-mass index (BMI): >= 18.5 kg/m² and <= 30.0 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 1 month
Key exclusion criteria (38 listed)
- Safety concerns
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
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 |
|---|---|---|
| GLA-015administration followed by PK blood sampling | Drug | GLA-015 |
| DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"administration followed by PK blood sampling | Drug | DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" |
Primary outcome
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of cannabidiol
Time frame: 24 hours
AUC144-168,ss = partial area under the concentration vs. time curve over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations)
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmax,144-168,ss of cannabidiol
Time frame: 24 hours
Cmax,144-168,ss = observed maximum concentration over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmin,144-168,ss of cannabidiol
Time frame: 24 hours
Cmin,144-168,ss = (absolute) minimum concentrations over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of 7-OH-CBD
Time frame: 24 hours
AUC144-168,ss = partial area under the concentration vs. time curve over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations)
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmax,144-168,ss, of 7-OH-CBD
Time frame: 24 hours
Cmax,144-168,ss = observed maximum concentration over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of Cmin,144-168,ss of 7-OH-CBD
Time frame: 24 hours
Cmin,144-168,ss = (absolute) minimum concentrations over both dosing intervals on PK profiling day (i.e. starting with the morning dose on study day 7 to 12 h after the evening dose on study day 7), considering scheduled times
2 secondary outcomes
Frequency of Adverse Events
Time frame: 14 days
Frequency of subjects showing Adverse Events
Time frame: 14 days
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 13 Jul 2021.
- 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.
Frank Donath principal investigator
SocraTec R&D GmbH Clinical Pharmacology Unit
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 GLA-015 and DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml" in people with Comparative Bioavailability, run by SocraTec R&D 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 6 inclusion and 38 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 13 Jul 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?
Comparison of relative bioavailability of Test vs. Reference after multiple dose administration after a light meal determined by use of AUC144-168,ss of cannabidiol (time frame: 24 hours). The study lists 6 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 13 Jul 2021.