Cannabidiol - an in Vivo Innovative Drug Delivery Study

Phase 1

Terminated

• Conditions: Pharmacokinetics, Bioavailability
• Interventions: Drug: Cannabidiol

• Registration Number: NCT03471559
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-20
• Study Start: 2018-12-10
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
New formulation	Cannabidiol	Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study)
Reference formulation	Cannabidiol	Cannabidiol capsule, 200 mg

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department I of Pharmacology, University of Cologne; 🇩🇪 Cologne, Germany