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    Clinical Trial Results:
    A randomized, pilot study to assess the impact of single nucleotide polymorphisms in the ABCB1 and ABCG2 genes on brain and organ distribution of dual Pgp/BCRP substrates in humans.

    Summary
    EudraCT number
    		 2012-005796-14
    Trial protocol
    		 AT  
    Global end of trial date
    05 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1/2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Klinische Pharmakologie, Medizinische Universität Wien, 0043 14040029810, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Klinische Pharmakologie, Medizinische Universität Wien, 0043 14040029810, klin-pharmakologie@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
    29 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    X To compare 11C-tariquidar and 11C-elacridar brain distribution before and during tariquidar infusion X To assess the influence of ABCB1 and ABCG2 SNPs on 11C-tariquidar and 11C-elacridar brain distribution before and during tariquidar infusion
    Protection of trial subjects
    During the trial subjects were under continous supervision of a physician or experienced nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2014
    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: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    27
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Volunteers will be recruited from an existing DNA database available at the Austrian Red Cross, Blood Service for Vienna, Lower Austria and Burgenland. From this database 3 groups of 20 individuals each with the following homozygous genotypes will be selected.

    Pre-assignment
    Screening details
    		 Group 1: 11C-Tariquidar Group 2: 11C-Elacridar Group 3: (R)-11C-verapamil

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 11C-tariquidar
    Arm type
    		 Active comparator

    Investigational medicinal product name
    11C-tariquidar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Two consecutive i.v. bolus injections of 11C-tariquidar with a maximum activity of 400 MBq. The estimated total effective dose per scan is 2.2 mSv for an i.v. injected activity amount of 400 MBq

    Arm title
    		 Group 2
    Arm description
    		 11C-elacridar
    Arm type
    		 Experimental

    Investigational medicinal product name
    11C-elacridar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Two consecutive i.v. bolus injections of (R)-11C-elacridar with a maximum activity of 400 MBq. The estimated total effective dose per scan is 2.2 mSv for an i.v. injected activity amount of 400 MBq

    Arm title
    		 Group 3
    Arm description
    		 11C-verapamil
    Arm type
    		 Experimental

    Investigational medicinal product name
    11C-verapamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Two consecutive i.v. bolus injections of (R)-11C-verapamil with a maximum activity of 400 MBq. The estimated total effective dose per scan is 2.2 mSv for an i.v. injected activity amount of 400 MBq

    Investigational medicinal product name
    11C-verapamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Two consecutive i.v. bolus injections of (R)-11C-verapamil with a maximum activity of 400 MBq. The estimated total effective dose per scan is 2.2 mSv for an i.v. injected activity amount of 400 MBq

    Number of subjects in period 1
    		Group 1 Group 2 Group 3
    Started
    15
    7
    5
    Completed
    15
    7
    5

    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
    		 27 27
    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)
    		 0 0
        From 65-84 years
    		 27 27
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 11C-tariquidar

    Reporting group title
    Group 2
    Reporting group description
    		 11C-elacridar

    Reporting group title
    Group 3
    Reporting group description
    		 11C-verapamil

    Primary: radioactivity concentration

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    End point title
    		 radioactivity concentration
    End point description
    End point type
    Primary
    End point timeframe
    1 hour
    End point values
    		 Group 1 Group 2 Group 3
    Number of subjects analysed
    15
    7
    5
    Units: kBq/ml
        number (not applicable)
    0.72
    0.054
    0.033
    Statistical analysis title
    		 VT
    Comparison groups
    Group 1 v Group 2 v Group 3
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    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 / 27 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 27 (92.59%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    5
    General disorders and administration site conditions
    Phlebitis
    Additional description: heat and redness on upper arm
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    Collapse
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Dysgeusia
    Additional description: metalic taste
         subjects affected / exposed
    15 / 27 (55.56%)
         occurrences all number
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Nov 2015
    Change of PI

    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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