Cannabidiol - an in Vivo Innovative Drug Delivery Study

Pharmacokinetics, Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03471559
• Other study ID #: CBD-DDS
• Status: Terminated
• Phase: Phase 1
• Start date: December 10, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: June 2020
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 29, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics, Bioavailability

Intervention

Drug:
• Cannabidiol
single or multiple dosing

Locations

Country	Name	City	State
Germany	Department I of Pharmacology, University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-8))	reference formulation compared to new formulation	36 hours
Primary	Pharmacokinetic profile of single dose - residual area	reference formulation compared to new formulation	36 hours
Primary	Pharmacokinetic profile of single dose - maximum concentration (Cmax)	reference formulation compared to new formulation	36 hours
Primary	Pharmacokinetic profile of single dose - time to reach Cmax (tmax)	reference formulation compared to new formulation	36 hours
Primary	Pharmacokinetic profile of single dose - elimination half life (t1/2)	reference formulation compared to new formulation	36 hours
Primary	Pharmacokinetic profile of single dose - elimination rate constant (?z)	reference formulation compared to new formulation	36 hours
Primary	Pharmacokinetic profile of multiple dosing - area under the curve (AUC(t))	reference formulation compared to new formulation	9 days
Primary	Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss)	reference formulation compared to new formulation	9 days
Primary	Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss)	reference formulation compared to new formulation	9 days
Primary	Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (t=12h))	reference formulation compared to new formulation	9 days
Primary	Pharmacokinetic profile of multiple dosing - steady state accumulation ratio	reference formulation compared to new formulation	9 days
Secondary	Regular laboratory testing	standard laboratory blood tests	36h or 9 days
Secondary	Electrocardiography - QTc time		36 hours or 9 days
Secondary	Vital signs - body temperature		36 hours or 9 days
Secondary	Vital signs - blood pressure	Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg)	36 hours or 9 days
Secondary	Vital signs - pulse rate		36 hours or 9 days