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    Clinical Trial Results:
    Detection of paracetamol concentration in blood-, saline- and urine samples with an electrochemical indicator in healthy volunteers - a validation study for a novel technique.

    Summary
    EudraCT number
    2020-002908-39
    Trial protocol
    FI  
    Global end of trial date
    06 Oct 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Dec 2023
    First version publication date
    03 Dec 2023
    Other versions
    Summary report(s)
    Introduction of an electrochemical point-of-care assay for quantitative determination of paracetamol in finger-prick capillary whole blood samples

    Trial information

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    Trial identification
    Sponsor protocol code
    FEPODPara2020-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04690673
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Helsinki University Hospital
    Sponsor organisation address
    Stenbäckinkatu 9, Helsinki, Finland, 00290
    Public contact
    Johanna Kujala, Helsinki University Hospital, johanna.kujala@helsinki.fi
    Scientific contact
    Johanna Kujala, Helsinki University Hospital, johanna.kujala@helsinki.fi
    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
    13 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We recruited 12 healthy volunteers, ages 18-45. They were delivered 1 g oral paracetamol. Paracetamol concentration was detected from abovementioned samples at timely intervals for 12 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis.
    Protection of trial subjects
    The trial included 12 volunteered adults, who were given one single dose of paracetamol 1 gram. This dose can be considered non-harmful. Data of the subjects and their privacy was considered carefully during and after the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Nov 2020
    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
    Finland: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The subjects were recruited by announcements in the social media platforms for university students. 15 persons volunteered. 3 persons were excluded from the study due to contraindications (medication or tobacco use). 12 were recruited.

    Pre-assignment
    Screening details
    Volunteers were recruited in accordance with the WMA Helsinki Declaration's ethical principles. For screening, medical history, laboratory tests including blood count, kidney and liver function and pregnancy tests for women, and physical examination were performed.

    Period 1
    Period 1 title
    Pharmacokinetic measurements (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was a pharmacokinetic study, no blinding.

    Arms
    Arm title
    Pharmacokinetic study
    Arm description
    All volunteers were introduced to the pharmacokinetic study
    Arm type
    Experimental

    Investigational medicinal product name
    Paracetamol
    Investigational medicinal product code
    Other name
    Acetaminophen
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The volunteers entered the study premises after overnight fasting. A single dose of oral paracetamol 1 g was administered with 200 ml lukewarm water.

    Number of subjects in period 1
    Pharmacokinetic study
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pharmacokinetic measurements
    Reporting group description
    Twelve healthy subjects aged 18–28 years, nine male, three female, European origin, were recruited; BMIs were 21—28 kg/m2 (median 23); all completed.

    Reporting group values
    Pharmacokinetic measurements Total
    Number of subjects
    12 12
    Age categorical
    All subjects were adults.
    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)
    12 12
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    9 9
    Subject analysis sets

    Subject analysis set title
    Pharmacokinetic study
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Volunteers ingested 1 g of paracetamol (Para-Tabs® 1 g, Orion Pharma, Finland) with 200 mL of water after overnight fasting. They had standardized meals four and eight hours after the paracetamol. Paired finger-prick and venous blood samples were collected prior to paracetamol administration, followed by sampling at timepoints 0.5; 1.0; 1.5; 2.0; 3.0; 4.0; 6.0; 8.0 and 12 h. Venous blood samples were centrifuged to plasma and frozen at -80°C for later HPLC-MS/MS analysis. Capillary finger-prick samples were collected for fast electrochemical POC analysis, and duplicate capillary blood samples with the VAMS Mitra® Cartridge Blood Sampling Device (Neoteryx, CA, USA) for later HPLC-MS/MS analysis.

    Subject analysis sets values
    Pharmacokinetic study
    Number of subjects
    12
    Age categorical
    All subjects were adults.
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    12
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    9

    End points

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    End points reporting groups
    Reporting group title
    Pharmacokinetic study
    Reporting group description
    All volunteers were introduced to the pharmacokinetic study

    Subject analysis set title
    Pharmacokinetic study
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Volunteers ingested 1 g of paracetamol (Para-Tabs® 1 g, Orion Pharma, Finland) with 200 mL of water after overnight fasting. They had standardized meals four and eight hours after the paracetamol. Paired finger-prick and venous blood samples were collected prior to paracetamol administration, followed by sampling at timepoints 0.5; 1.0; 1.5; 2.0; 3.0; 4.0; 6.0; 8.0 and 12 h. Venous blood samples were centrifuged to plasma and frozen at -80°C for later HPLC-MS/MS analysis. Capillary finger-prick samples were collected for fast electrochemical POC analysis, and duplicate capillary blood samples with the VAMS Mitra® Cartridge Blood Sampling Device (Neoteryx, CA, USA) for later HPLC-MS/MS analysis.

    Primary: Cmax POC Capillary

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    End point title
    Cmax POC Capillary [1]
    End point description
    Pharmacokinetic parameters of paracetamol from capillary whole blood samples with the novel electrochemical point-of-care (POC) method
    End point type
    Primary
    End point timeframe
    0- 12 hours.
    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 is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage.
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: mmol/l
        geometric mean (geometric coefficient of variation)
    101.73 ( 21 )
    No statistical analyses for this end point

    Primary: Tmax POC Capillary

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    End point title
    Tmax POC Capillary [2]
    End point description
    Pharmacokinetic parameters of paracetamol from capillary whole blood samples with the novel electrochemical point-of-care (POC) method
    End point type
    Primary
    End point timeframe
    0-12 h
    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 is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage.
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: hour
        median (full range (min-max))
    0.5 (0.5 to 2)
    No statistical analyses for this end point

    Primary: AUC 0-last POC Capillary

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    End point title
    AUC 0-last POC Capillary [3]
    End point description
    Pharmacokinetic parameters of paracetamol from capillary whole blood samples with the novel electrochemical point-of-care (POC) method
    End point type
    Primary
    End point timeframe
    0-12 h
    Notes
    [3] - 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 is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage.
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: h µmol/l
        geometric mean (geometric coefficient of variation)
    330.60 ( 29 )
    No statistical analyses for this end point

    Primary: Cmax HPLC-MS/MS venous plasma

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    End point title
    Cmax HPLC-MS/MS venous plasma [4]
    End point description
    Pharmacokinetic parameters of paracetamol from venous plasma samples measured with HPLC-MS/MS.
    End point type
    Primary
    End point timeframe
    0-12 h
    Notes
    [4] - 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 is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage.
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: µM
        geometric mean (geometric coefficient of variation)
    65.61 ( 27 )
    No statistical analyses for this end point

    Primary: Tmax HPLC-MS/MS venous plasma

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    End point title
    Tmax HPLC-MS/MS venous plasma [5]
    End point description
    Pharmacokinetic parameters of paracetamol from venous plasma samples measured with HPLC-MS/MS.
    End point type
    Primary
    End point timeframe
    0-12 h
    Notes
    [5] - 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 is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage.
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: hour
        median (full range (min-max))
    1.0 (0.5 to 2.0)
    No statistical analyses for this end point

    Primary: AUC 0-last HPLC-MS/MS venous plasma

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    End point title
    AUC 0-last HPLC-MS/MS venous plasma [6]
    End point description
    Pharmacokinetic parameters of paracetamol from venous plasma samples measured with HPLC-MS/MS.
    End point type
    Primary
    End point timeframe
    0-12 h
    Notes
    [6] - 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 is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage.
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: h µmol/L
        geometric mean (geometric coefficient of variation)
    262.21 ( 26 )
    No statistical analyses for this end point

    Secondary: Cmax HPLC-MS/MS capillary

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    End point title
    Cmax HPLC-MS/MS capillary
    End point description
    Pharmacokinetic parameters of paracetamol from capillary whole blood samples measured with HPLC-MS/MS.
    End point type
    Secondary
    End point timeframe
    0-12 h
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: µM
        geometric mean (geometric coefficient of variation)
    98.67 ( 31 )
    No statistical analyses for this end point

    Secondary: Tmax HPLC-MS/MS capillary

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    End point title
    Tmax HPLC-MS/MS capillary
    End point description
    Pharmacokinetic parameters of paracetamol from capillary whole blood samples measured with HPLC-MS/MS.
    End point type
    Secondary
    End point timeframe
    0-12 h
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: hour
        median (full range (min-max))
    0.5 (0.5 to 2.0)
    No statistical analyses for this end point

    Secondary: AUC 0-last HPLC-MS/MS from capillary

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    End point title
    AUC 0-last HPLC-MS/MS from capillary
    End point description
    Pharmacokinetic parameters of paracetamol from capillary whole blood samples measured with HPLC-MS/MS.
    End point type
    Secondary
    End point timeframe
    0-12 h
    End point values
    Pharmacokinetic study
    Number of subjects analysed
    12
    Units: h µmol/L
        geometric mean (geometric coefficient of variation)
    283.41 ( 30 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 h
    Adverse event reporting additional description
    The subjects received a standard 1g dose of paracetamol. The samples were collected within 12 hours from paracetamol intake. No adverse effects were reported.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.1
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The volunteers were provided with 1 g of paracetamol with no adverse effects noticed from the drug. Venous and capillary blood samples were collected during 12 hours. No noticeable adverse effects occurred during sample collection.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/37218304
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