Cannabidiol - an in Vivo Innovative Drug Delivery Study

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

Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.

Study Overview

• Status: Terminated
• Conditions: Pharmacokinetics, Bioavailability
• Intervention / Treatment: Drug: Cannabidiol

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50931
    • Department I of Pharmacology, University of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Institute of Mental Health, Mannheim
• Investigators: Principal Investigator: Uwe Fuhr, MD, Department I of Pharmacology, University of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticonvulsants; Cannabidiol
• Other Study ID Numbers: CBD-DDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No