Clinical trial NCT03471559: Cannabidiol - an in Vivo Innovative Drug Delivery Study
Official title: Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pharmacokinetics, Bioavailability
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞))
timeFrame: 36 hours
measure: Pharmacokinetic profile of single dose - residual area
timeFrame: 36 hours
measure: Pharmacokinetic profile of single dose - maximum concentration (Cmax)
timeFrame: 36 hours
measure: Pharmacokinetic profile of single dose - time to reach Cmax (tmax)
timeFrame: 36 hours
measure: Pharmacokinetic profile of single dose - elimination half life (t1/2)
timeFrame: 36 hours
measure: Pharmacokinetic profile of single dose - elimination rate constant (λz)
timeFrame: 36 hours
measure: Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ))
timeFrame: 9 days
measure: Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss)
timeFrame: 9 days
measure: Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss)
timeFrame: 9 days
measure: Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h))
timeFrame: 9 days
measure: Pharmacokinetic profile of multiple dosing - steady state accumulation ratio
timeFrame: 9 days
Secondary outcomes:
measure: Regular laboratory testing
timeFrame: 36h or 9 days
measure: Electrocardiography - QTc time
timeFrame: 36 hours or 9 days
measure: Vital signs - body temperature
timeFrame: 36 hours or 9 days
measure: Vital signs - blood pressure
timeFrame: 36 hours or 9 days
measure: Vital signs - pulse rate
timeFrame: 36 hours or 9 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department I of Pharmacology, University of Cologne
Study officials:
affiliation: Department I of Pharmacology, University of Cologne
name: Uwe Fuhr, MD
role: PRINCIPAL_INVESTIGATOR
References: