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    Summary
    EudraCT Number:2019-002786-35
    Sponsor's Protocol Code Number:CUA1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2019-002786-35
    A.3Full title of the trial
    Pharmacokinetics and side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease and patients on dialysis.
    Farmakokinetik og bivirkninger for tetrahydrocannabinol og cannabidiol (Sativex) hos patienter med nyreinsufficiens og patienter i dialyse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Excretion and side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease and patients on dialysis.
    Udskillelse og bivirkninger for tetrahydrocannabinol og cannabidiol (Sativex) hos patienter med nyreinsufficiens og patienter i dialyse.
    A.3.2Name or abbreviated title of the trial where available
    PK cannabinoids
    PK cannabinoider
    A.4.1Sponsor's protocol code numberCUA1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCharlotte Uggerhøj Andersen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAarhus University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Regions
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Health Research Foundation of Central Denmark Region
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportHelsefonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportA.P. Møller Fonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNyreforeningen
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAugustinus Fonden
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressVennelyst Boulevard 4, Aarhus University
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailcua@biomed.au.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sativex
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma (International) B.V., represented by Almirall ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDelta-9-tetrahydrocannabinol
    D.3.9.3Other descriptive nameDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease
    Kronisk nyreinsufficiens
    E.1.1.1Medical condition in easily understood language
    Kidney disease
    Nyresygdom
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the pharmacokinetics for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease compared healthy volunteers.
    At belyse, hvorvidt nyresyge har en ændret farmakokinetik for tetrahydrocannabinol og cannabidiol (Sativex) ift. ikke nyresyge.
    E.2.2Secondary objectives of the trial
    To investigate the occurrence of side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease compared healthy volunteers.
    At belyse, hvorvidt nyresyge har en ændret forekomst af bivirkninger til tetrahydrocannabinol og cannabidiol (Sativex) ift. ikke nyresyge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent, age ≥18 years and competent.
    - For fertile women defined as amenorrhea for less than 12 months: Negative HCG pregnancy test before study start.
    - For fertile and sexual active participants: Use of safe contraception under and 3 months after the study, i.e. intrauterine device or hormonal contraception (oral, implantable, transdermal, intravaginal, injectable). Sterile or infertile study participants are exempted from the demand to use contraception. To be considered as sterile or infertile one must generally be surgical sterilised (vasectomy/ bilateral tubectomy, hysterectomy and bilateral oophorectomy) or postmenopausal, defined as amenorrhea for 12 months, as a minimum, before study inclusion.
    - For participants using hormonal contraception: Informed about and expressed acceptance of use of an additional barrier method e.g. male condom during and 3 months after the study.
    - For male participants with fertile partners: Informed about and expressed acceptance of use of condom during and 3 months after the study.
    - Dependent on the study participant subgroup: For group 1: eGFR ≤30 mL/min and >15 mL/min. For group 2: eGFR ≤15 mL/min. For group 3: eGFR >60 mL/min. For group 4: chronic kidney disease and treatment with dialysis.
    - Informeret skriftligt samtykke, alder >=18 år, habil, myndig.
    - For fertile kvinder defineret ved amenorré i mindre end 12 måneder: negativ HCG inden indtræden i forsøget.
    - For fertile og seksuelt aktive forsøgspersoner: anvendelse af sikker antikonception under medicinindtag samt 3 måneder efter, dvs. spiral eller hormonel antikonception (p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion). Sterile eller infertile forsøgsdeltagere er fritaget for kravet om brug af antikonception. For at betragtes som steril eller infertil må man almindeligvis være kirurgisk steriliseret (vasektomi/bilateral tubektomi, hysterektomi og bilateral ovarektomi) eller være postmenopausal, defineret som amenorré i mindst 12 måneder før studie indrullering.
    - For deltagere, der anvender hormonel antikonception: Informeret om og har udtrykt accept af, at der yderligere skal anvendes en barrieremetode fx mandligt kondom under og 3 måneder efter studiet.
    - For mandlige forsøgsdeltagere med fertile partnere: Informeret om og har udtrykt accept af, at der skal anvendes kondom under og 3 måneder efter studiet.
    - Særligt for de relevante undergrupper af forsøgspersoner: For gruppe 1: eGFR <=30 ml/min og >15 ml/min. For gruppe 2: eGFR <=15 ml/min. For gruppe 3: eGFR >60 ml/min. For gruppe 4: dialysekrævende nyresygdom behandlet med dialyse.
    E.4Principal exclusion criteria
    - Psychiatric disorder with psychotic symptoms or risk of psychotic symptoms, including schizophrenia as well as schizophrenia in the closest biologic family or previous suicide attempt.
    - Alcohol abuse or other abuse.
    - Treatment with benzodiazepines, benzodiazepine-like medication, opioids or warfarin.
    - Treatment with or other use of products containing THC and/or CBD within 2 months.
    - Treatment with strong inhibitors/inducers of CYP3A4, CYP2C19 or CYP2C9 or medicinal products with known potential of clinical significant interaction with THC and/or CBD, which cannot be paused or substituted for a period of five half-lives of the specific medicine before and during the study.
    - Known unstable angina pectoris, known heart failure with ejection fraction <20%, known treatment-resistant hypertension grade 3 (systolic ≥175 mmHg or diastolic ≥105 mmHg) or significantly impaired liver function.
    - Pregnancy or breastfeeding.
    - Known epilepsy.
    - Known allergic reaction to any of the ingredients in Sativex.
    - Psykiatrisk lidelse med forekomst af eller risiko for forekomst af psykotiske symptomer, herunder skizofreni samt skizofreni i nærmeste biologiske familie eller tidligere selvmordsforsøg.
    - Alkohol- eller anden form for misbrug.
    - Behandling med benzodiazepiner, benzodiazepinlignende stoffer, opioider eller warfarin.
    - Behandling med eller brug af THC og/eller CBD inden for 2 måneder.
    - Behandling med kendte stærke hæmmere/inducere af CYP3A4, CYP2C19 og CYP2C9 eller lægemidler med kendt klinisk betydende interaktionspotentiale med THC og/eller CBD, der ikke kan pauseres eller substitueres i en periode svarende til 5 halveringstider af det pågældende stof forud for forsøget samt under forsøget.
    - Kendt ustabil angina pectoris, kendt hjerteinsufficiens med ejektions fraktion <20%, kendt svær behandlingsrefraktær hypertension sv.t. grad 3 (systolisk blodtryk ≥175 mmHg eller diastolisk blodtryk ≥105 mmHg) eller betydende leverinsufficiens.
    - Kendt graviditet eller pågående amning.
    - Kendt epilepsi.
    - Kendt allergi over for indholdsstoffer i Sativex.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the AUC (area under the curve) of THC measured in blood from Sativex is administrated until 24 hours post-dosing.
    Det primære endepunkt er THC’s AUC målt i blodet over 24 timer fra indtaget af en dosis Sativex
    E.5.1.1Timepoint(s) of evaluation of this end point
    The AUC is measured from Sativex is administrated until 24 hours post-dosing. Blood samples are drawn: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dosing.
    AUC måles over 24 timer efter indtag af Sativex. Der udtages blodprøver: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 og 24 timer efter dosering.
    E.5.2Secondary end point(s)
    - Maximum concentration (Cmax) and time to maximum concentration (Tmax) of THCA, THC, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD and 7-OH-CBD in blood.
    - AUC of THCA, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD and 7-OH-CBD in blood over 24 hours.
    - The total excretion in urine and dialysate (for group 4) of THCA, THC, 11-OH-THC, THC-COOH, CBDA, CBD and 7-OH-CBD over 24 hours.
    - The prevalence of side effects in the first 24 hours after the medicine is administrated, assessed on a numeric rating scale (NRS) from 0 to 10.
    - Den maksimalt opnåede koncentration (Cmax) og tid til maksimal koncentration (Tmax) for THCA, THC, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD og 7-OH-CBD i blodet.
    - AUC for THCA, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD og 7-OH-CBD i blodet målt over 24 timer.
    - Total udskillelse af THCA, THC, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD og 7-OH-CBD i urin og dialysevæske (for gruppe 4) målt over 24 timer.
    - Forekomst af bivirkninger de første 24 timer efter indtag af forsøgsmedicinen vurderet ved numeric rating scale (NRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end points is measured from Sativex is administrated until 24 hours post-dosing.
    Alle endepunkter måles over 24 timer fra indtag af Sativex.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic trial in patients with chronic kidney disease
    Farmakokinetisk studie i patienter med nyreinsufficiens
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Patienter med forskellige stadier af kronisk nyreinsufficiens er sammenlignet med raske frivillige
    Patients with different stages of chronic kidney disease are compared to healthy volunteers
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject undergoing the trial
    Sidste besøg for sidste forsøgsdeltager i studiet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with chronic kidney disease
    Patienter med kronisk nyreinsufficiens
    F.4 Planned number of subjects to be included
    F.4.1In the member state85
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None. The patients will continue their normal treatment regime.
    Ingen. Patienterne vil fortsætte deres vanlige behandling.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Aarhus University Hospital, Department of Renal Medicine
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Hospitalsapoteket Region Midtjylland
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
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