NCT03471559

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

March 7, 2018

Last Update Submit

June 29, 2020

Conditions

Pharmacokinetics, Bioavailability

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (5)

  • Regular laboratory testing

    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

    36 hours or 9 days

  • Vital signs - pulse rate

    36 hours or 9 days

Study Arms (2)

Reference formulation

ACTIVE COMPARATOR

Cannabidiol capsule, 200 mg

Drug: Cannabidiol

New formulation

EXPERIMENTAL

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

Drug: Cannabidiol

Interventions

CannabidiolDRUG

single or multiple dosing

New formulationReference formulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department I of Pharmacology, University of Cologne

Cologne, 50931, Germany

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Uwe Fuhr, MD

    Department I of Pharmacology, University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 20, 2018

Study Start

December 10, 2018

Primary Completion

June 30, 2019

Study Completion

August 29, 2019

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)