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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

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics, Bioavailability Drug: Cannabidiol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : August 31, 2019

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




Primary Outcome Measures :
  1. Pharmacokinetic profile of single dose - area under the curve (AUC(0-t)), AUC(0-∞)) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation

  2. Pharmacokinetic profile of single dose - residual area [ Time Frame: 36 hours ]
    reference formulation compared to new formulation

  3. Pharmacokinetic profile of single dose - maximum concentration (Cmax) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation

  4. Pharmacokinetic profile of single dose - time to reach Cmax (tmax) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation

  5. Pharmacokinetic profile of single dose - elimination half life (t1/2) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation

  6. Pharmacokinetic profile of single dose - elimination rate constant (λz) [ Time Frame: 36 hours ]
    reference formulation compared to new formulation

  7. Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ)) [ Time Frame: 9 days ]
    reference formulation compared to new formulation

  8. Pharmacokinetic profile of multiple dosing - maximum concentration (Cmax,ss) [ Time Frame: 9 days ]
    reference formulation compared to new formulation

  9. Pharmacokinetic profile of multiple dosing - time to reach Cmax (tmax,ss) [ Time Frame: 9 days ]
    reference formulation compared to new formulation

  10. Pharmacokinetic profile of multiple dosing - elimination half life (t1/2,ss (τ=12h)) [ Time Frame: 9 days ]
    reference formulation compared to new formulation

  11. Pharmacokinetic profile of multiple dosing - steady state accumulation ratio [ Time Frame: 9 days ]
    reference formulation compared to new formulation


Secondary Outcome Measures :
  1. Regular laboratory testing [ Time Frame: 36h or 9 days ]
    standard laboratory blood tests

  2. Electrocardiography - QTc time [ Time Frame: 36 hours or 9 days ]
  3. Vital signs - body temperature [ Time Frame: 36 hours or 9 days ]
  4. Vital signs - blood pressure [ Time Frame: 36 hours or 9 days ]
    Systolic and diastolic blood pressure reported in millimetres of mercury (mmHg)

  5. Vital signs - pulse rate [ Time Frame: 36 hours or 9 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471559


Contacts
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Contact: F. Markus Leweke, MD +49 621 1703 2302 leweke@cimh.de

Locations
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Germany
Department I of Pharmacology, University of Cologne Recruiting
Cologne, Germany, 50931
Contact: Uwe Fuhr, MD       uwe.fuhr@uk-koeln.de   
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
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Principal Investigator: Uwe Fuhr, MD Department I of Pharmacology, University of Cologne

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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT03471559     History of Changes
Other Study ID Numbers: CBD-DDS
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epidiolex
Anticonvulsants