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    Clinical Trial Results:
    A pilot study to assess [11C]elacridar and [11C]tariquidar as two positron emission tomography radiotracers for visualization of P-glycoprotein in humans.

    Summary
    EudraCT number
    		 2010-020759-30
    Trial protocol
    		 AT  
    Global end of trial date
    15 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2019
    First version publication date
    12 Jul 2019
    Other versions
    Summary report(s)
    		 Interaction of C11-tariquidar and C11-elacridar

    Trial information

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    Trial identification
    Sponsor protocol code
    [11C]inhibitors
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090
    Public contact
    Markus Zeitlinger, MD , Medical University of Vienna, Department of Clinical Pharmacology, 0043 140400 29810, markus.zeitlinger@meduniwien.ac.at
    Scientific contact
    Markus Zeitlinger, MD , Medical University of Vienna, Department of Clinical Pharmacology, 0043 140 400 29810, markus.zeitlinger@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Study group 1: To assess the utility of [11C]elacridar and [11C]tariquidar for the visualization of P-gp at the human blood-brain barrier. Study group 2: To gain data about whole body biodistribution and organ wise radiation dosimetry of [11C]elacridar and [11C]tariquidar in humans.
    Protection of trial subjects
    Subjects were during the trial under the supervision of a physician or an experienced nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited by use of the data base of the Dep. of Clinical Pharmacology, Medical University Vienna

    Pre-assignment
    Screening details
    		 Check of the In- and Exclusion criteria, Physical examination, Vital signs, Laboratory assessment and ECG recording

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 two parallel groups
    Arm description
    		 The study will be performed as a pilot clinical PET-study in two parallel groups.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tariquidar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous drip use
    Dosage and administration details
    [11C]tariquidar at a tracer dose of less than 20 µg corresponding to a maximum activity of 400 MBq as an i.v. bolus. Tariquidar at a dose of 4 mg/kg body weight, given once as an i.v. infusion.

    Investigational medicinal product name
    Elacridar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    [11C]elacridar at a tracer dose of less than 20 µg corresponding to a maximum activity of 400 MBq as an i.v. bolus.

    Investigational medicinal product name
    Verapamil
    Investigational medicinal product code
    C08DA01
    Other name
    Isoptin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    (R)-[11C]verapamil at a tracer dose of less than 20 µg corresponding to a maximum activity of 400 MBq as an i.v. bolus, at an interval of approximately 4 h after the [11C]elacridar or [11C]tariquidar injection.

    Number of subjects in period 1
    		two parallel groups
    Started
    24
    Completed
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    two parallel groups
    Reporting group description
    		 The study will be performed as a pilot clinical PET-study in two parallel groups.

    Primary: Brain time-activity curves of [11C]elacridar, [11C]tariquidar and (R)-[11C]verapamil before and after infusion of 4 mg/kg body weight tariquidar

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    End point title
    		 Brain time-activity curves of [11C]elacridar, [11C]tariquidar and (R)-[11C]verapamil before and after infusion of 4 mg/kg body weight tariquidar [1]
    End point description
    End point type
    Primary
    End point timeframe
    0-120 min
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study group consists of two radiotracer applications in different subjects, no in between group statistics has been performed
    End point values
    		 two parallel groups
    Number of subjects analysed
    12
    Units: Bq/ml
        number (not applicable)
    12
    No statistical analyses for this end point

    Primary: [11C]elacridar and [11C]tariquidar radiation dose in different organs, normalized to injected dose and expressed as mSv/MBq

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    End point title
    		 [11C]elacridar and [11C]tariquidar radiation dose in different organs, normalized to injected dose and expressed as mSv/MBq [2]
    End point description
    End point type
    Primary
    End point timeframe
    0-120min
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study group comprises radiation dosimetry measurements only, so no statistics was done
    End point values
    		 two parallel groups
    Number of subjects analysed
    12
    Units: Bq/ml
        number (not applicable)
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from 11.03.2011 to 26.03.2013
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 24 (62.50%)
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    General disorders and administration site conditions
    Hot flush
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Dysgeusia
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    7
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2011
    deletion of Exclusion criteria for study Group 2: Study group 2 only - weight: 60 – 85 kg and height: 170 – 185 cm
    07 Jun 2011
    One additional PET-Scan on the study day. IMP dose reduction of Tariquidar from 4 mg/kg body weight to 3 mg/kg body weight
    10 Jun 2012
    additional genetic Analysis of BCRP (breast cancer resistance Protein)

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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