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Cannabidiol - an in Vivo Innovative Drug Delivery Study

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ClinicalTrials.gov Identifier: NCT03471559
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date December 13, 2018
Actual Study Start Date  ICMJE December 10, 2018
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞)) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - residual area [ Time Frame: 36 hours ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - maximum concentration (Cmax) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - time to reach Cmax (tmax) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - elimination half life (t1/2) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - elimination rate constant (λz) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ)) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h)) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - steady state accumulation ratio [ Time Frame: 9 days ]
    reference formulation compared to new formulation
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞)) [ Time Frame: 36 h ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - residual area [ Time Frame: 36 h ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - maximum concentration (Cmax) [ Time Frame: 36 h ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - time to reach Cmax (tmax) [ Time Frame: 36 h ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - elimination half life (t1/2) [ Time Frame: 36 h ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of single dose - elimination rate constant (λz) [ Time Frame: 36 h ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ)) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h)) [ Time Frame: 9 days ]
    reference formulation compared to new formulation
  • Pharmacokinetic profile of multiple dosing - steady state accumulation ratio [ Time Frame: 9 days ]
    reference formulation compared to new formulation
Change History Complete list of historical versions of study NCT03471559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Regular laboratory testing [ Time Frame: 36h or 9 days ]
    standard laboratory blood tests
  • Electrocardiography - QTc time [ Time Frame: 36 hours or 9 days ]
  • Vital signs - body temperature [ Time Frame: 36 hours or 9 days ]
  • Vital signs - blood pressure [ Time Frame: 36 hours or 9 days ]
    Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg)
  • Vital signs - pulse rate [ Time Frame: 36 hours or 9 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Regular laboratory testing [ Time Frame: 36h or 9 days ]
    standard laboratory blood tests
  • Electrocardiography - QTc time [ Time Frame: 36h or 9 days ]
  • Vital signs - body temperature [ Time Frame: 36h or 9 days ]
  • Vital signs - blood pressure [ Time Frame: 36h or 9 days ]
  • Vital signs - pulse rate [ Time Frame: 36h or 9 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol - an in Vivo Innovative Drug Delivery Study
Official Title  ICMJE Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics, Bioavailability
Intervention  ICMJE Drug: Cannabidiol
single or multiple dosing
Study Arms  ICMJE
  • Active Comparator: Reference formulation
    Cannabidiol capsule, 200 mg
    Intervention: Drug: Cannabidiol
  • Experimental: New formulation
    Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study)
    Intervention: Drug: Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: F. Markus Leweke, MD +49 621 1703 2302 leweke@cimh.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03471559
Other Study ID Numbers  ICMJE CBD-DDS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Central Institute of Mental Health, Mannheim
Study Sponsor  ICMJE Central Institute of Mental Health, Mannheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Uwe Fuhr, MD Department I of Pharmacology, University of Cologne
PRS Account Central Institute of Mental Health, Mannheim
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP