Status:
COMPLETED
Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration
Lead Sponsor:
SocraTec R&D GmbH
Collaborating Sponsors:
Glatt Pharmaceutical Services GmbH & Co. KG
SocraMetrics GmbH
Conditions:
Comparative Bioavailability
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 C...
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) heal...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04790136
Start Date
March 17 2021
End Date
May 12 2021
Last Update
July 13 2021
Active Locations (1)
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1
SocraTec R&D GmbH Clinical Pharmacology Unit
Erfurt, Thuringia, Germany, 99084