Cannabidiol - an in Vivo Innovative Drug Delivery Study

NCT ID: NCT03471559

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2019-08-29

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.

Conditions

Pharmacokinetics, Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Reference formulation

Cannabidiol capsule, 200 mg

Group Type: ACTIVE_COMPARATOR

Cannabidiol

Intervention Type: DRUG

single or multiple dosing

New formulation

Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study)

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

single or multiple dosing

Interventions

Cannabidiol

single or multiple dosing

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Fuhr, MD

Role: PRINCIPAL_INVESTIGATOR

Department I of Pharmacology, University of Cologne

Locations

Department I of Pharmacology, University of Cologne

Cologne, , Germany

Countries

Germany

Other Identifiers

CBD-DDS

Identifier Type: -

Identifier Source: org_study_id