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    Summary
    EudraCT Number:2015-001593-18
    Sponsor's Protocol Code Number:958
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-001593-18
    A.3Full title of the trial
    A pilot study to assess the influence of drug transporters on brain and organ distribution of erlotinib in humans
    Eine Pilotstudie zur Untersuchung des Einflusses von Transportern auf die Gehirn- und Organ- Verteilung von Erlotinib im Menschen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To study the influence of drug transporters on the distribution of erlotinib in different organs of the human body
    A.3.2Name or abbreviated title of the trial where available
    [11C]erlotinib
    A.4.1Sponsor's protocol code number958
    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 SponsorMedizinische Universiät Wien
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien
    B.5.2Functional name of contact pointKlinische Pharmakologie
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    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 Tarceva
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameErlotinib
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 No
    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.3.1Product nameTariquidar
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXR9576
    D.3.9.1CAS number 206873-63-4
    D.3.9.3Other descriptive nameTARIQUIDAR
    D.3.9.4EV Substance CodeSUB33149
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7.13 to 7.88
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Rifoldin
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.1Product nameRifoldin
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIFAMPICIN
    D.3.9.1CAS number 13292-46-1
    D.3.9.4EV Substance CodeSUB10309MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Investigation in volunteers only
    E.1.1.1Medical condition in easily understood language
    No medical condition investigated
    E.1.1.2Therapeutic area Body processes [G] - Chemical Phenomena [G02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
     To compare distribution of [11C]erlotinib to the brain and to peripheral organs (liver, gall bladder, intestine, kidneys, lungs) without and with co-administration of a therapeutic dose of erlotinib
     To compare distribution of [11C]erlotinib to peripheral organs without and with co-administration of a therapeutic dose of rifampicin
     To investigate whether PET with a microdose of [11C]erlotinib can predict tissue distribution of a therapeutic dose of erlotinib
     To compare distribution of [11C]erlotinib to the brain and to peripheral organs (liver, gall bladder, intestine, kidneys, lungs) without and with co-administration of the ABCB1 inhibitor tariquidar
     To obtain information regarding whole-body radiation dosimetry of [11C]erlotinib in humans
     To assess the utility of [11C]erlotinib for visualization of ABC transporters (ABCB1, ABCG2) at the human BBB and other peripheral organs
     To assess image derived input function for liver blood vessels with PET/MR
    E.2.2Secondary objectives of the trial
     To assess the safety and tolerability of [11C]erlotinib PET
     To assess radiolabelled metabolites of [11C]erlotinib in plasma
     To develop a kinetic model for quantification of [11C]erlotinib PET data in brain and peripheral organs
     To investigate whole-body biodistribution of [11C]erlotinib in humans
     To assess possible gender differences in [11C]erlotinib distribution
     To assess a dose-response relationship for enhancement of [11C]erlotinib PET signal in the brain after 300-1000 mg erlotinib p.o.-
     To investigate the feasibility of MR based assessment of liver blood flow.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Non-smokers
    • Age: >18 and < 55 years old
    • No disease interfering with the study objectives (at investigators´ discretion)
    • Normotensive after 5 min rest
    • Normofrequent after 5 min rest
    • No contraindication for MRI
    • No known hypersensitivity to any of the components of the administered substances and diagnostics
    • Volunteers must sign the informed consent prior to inclusion in the study

    • Inclusion criteria for patients of group 5 only:
    o Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
    o Patients with an intrahepatic shunt undergoing measurement of portosystemic pressure gradient to assess shunt function for clinical routine purposes (one previous measurement is required)
    o Moderate nicotine consumption is allowed for this group
    E.4Principal exclusion criteria
    • Smokers
    • Abnormalities found in blood and urine laboratory tests as part of the pretreatment screening or in any of the laboratory tests performed that the investigator considers clinically relevant
    • Presence of any ECG abnormalities, which the investigator considers clinically relevant
    • Abnormalities in the medical history (e.g. history of or current ethanol abuse, allergies, co-morbidities, anticoagulation with Marcoumar®) that might influence the outcome of the study or might result in inacceptable risks for the subject according to investigators judgment.
    • History of drug and alcohol abuse
    • Contraindication to arterial cannulation (e.g. intake of anticoagulants of any kind)
    • Blood donation within 1 month before the start of the study
    • Participation in a clinical study with radioactive substances if exposure exceeds the maximum foreseen radiation of the current guidelines
    • Intake of any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study, due to interference with CYP3A4, ABCB1 or ABCG2 (ABCB1 inducers such as St. John’s wort, docetaxel, etoposide, vincristine, cyclosporine, tacrolimus, macrolides, lovastatin, digoxin, digitoxin, carvedilol, rifampicin or inhibitors such as esomprazol, omeprazole, pantoprazole, lansoprazole, atorvastatin, itraconazol) or may cause potential harm to the subject (drug-drug interaction between tariquidar and loperamide or quinidine)
    • Subjects with Galactose-Intolerance, Lactase-Deficiency or Glucose-Galactose –Malabsorption (erlotinib tablets contain lactose)
    • For female subjects in child-bearing age: Pregnancy or breastfeeding
    • Exclusion criteria for patients of group 5 only:
    o A medical condition or drug treatment interfering with the study objectives (at investigators´ discretion)
    o Absolute contraindication for PET/MRI investigation
    o Patients with history of alcohol abuse who are currently abstinent
    o Presence of any ECG or other abnormalities, which the investigator considers clinically relevant
    o Participation in a clinical study with radioactive substances if exposure exceeds the maximum foreseen radiation of the current guidelines
    E.5 End points
    E.5.1Primary end point(s)
     Outcome parameters from pharmacokinetic modelling of [11C]erlotinib PET data (total volume of distribution VT, rate constants for transfer of [11C]erlotinib between plasma and organ compartments)
     Changes in [11C]erlotinib modelling outcome parameters in scans acquired after erlotinib and during tariquidar administration compared to outcome parameters measured before erlotinib and tariquidar administration
     [11C]erlotinib radiation dose in different organs normalized to injected dose, and expressed as mSv/MBq.
     Image derived input functions of portal vein and hepatic artery (or abdominal aorta) reflecting radioactivity concentrations for the blood in the respective vessels. MR based assessment of liver blood flow will be investigated as well.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study
    E.5.2Secondary end point(s)
     Influence of erlotinib and tariquidar administration on percentage of radiolabelled metabolites in plasma
     Safety and tolerability of [11C]erlotinib PET imaging
     Whole-body distribution of [11C]erlotinib expressed as SUV
     Sex differences in [11C]erlotinib distribution
     ABCB1/ABCG2 genotype of the study participants
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state87
    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)
    Volunteers recruited from Hepatology Department will receive treatment as usual at the local outpatients clinic.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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