Cannabidiol - an in Vivo Innovative Drug Delivery Study

Study Overview
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Brief Summary
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Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.

Detailed Description
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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.

Official Title
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Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study

Conditions
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Pharmacokinetics, Bioavailability

Intervention / Treatment
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* Drug: Cannabidiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference formulation<br>Cannabidiol capsule, 200 mg | Drug: Cannabidiol<br>* single or multiple dosing<br>|
| Experimental: New formulation<br>Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study) | Drug: Cannabidiol<br>* single or multiple dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞)) | reference formulation compared to new formulation | 36 hours | 
| Pharmacokinetic profile of single dose - residual area | reference formulation compared to new formulation | 36 hours | 
| Pharmacokinetic profile of single dose - maximum concentration (Cmax) | reference formulation compared to new formulation | 36 hours | 
| Pharmacokinetic profile of single dose - time to reach Cmax (tmax) | reference formulation compared to new formulation | 36 hours | 
| Pharmacokinetic profile of single dose - elimination half life (t1/2) | reference formulation compared to new formulation | 36 hours | 
| Pharmacokinetic profile of single dose - elimination rate constant (λz) | reference formulation compared to new formulation | 36 hours | 
| Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ)) | reference formulation compared to new formulation | 9 days | 
| Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) | reference formulation compared to new formulation | 9 days | 
| Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) | reference formulation compared to new formulation | 9 days | 
| Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h)) | reference formulation compared to new formulation | 9 days | 
| Pharmacokinetic profile of multiple dosing - steady state accumulation ratio | reference formulation compared to new formulation | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regular laboratory testing | standard laboratory blood tests | 36h or 9 days | 
| Electrocardiography - QTc time |  | 36 hours or 9 days | 
| Vital signs - body temperature |  | 36 hours or 9 days | 
| Vital signs - blood pressure | Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg) | 36 hours or 9 days | 
| Vital signs - pulse rate |  | 36 hours or 9 days |