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    Clinical Trial Results:
    A single center, randomized, open-label, cross-over exploratory study to evaluate the pharmacodynamic and pharmacokinetic response to a subcutaneous administration or oral administration of furosemide in subjects presenting with chronic fluid overload

    Summary
    EudraCT number
    		 2014-002546-49
    Trial protocol
    		 NL  
    Global end of trial date
    08 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2023
    First version publication date
    20 Mar 2023
    Other versions
    Summary report(s)
    		 SCP-01-001 Synopsis Report

    Trial information

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    Trial identification
    Sponsor protocol code
    SCP-01-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02350725
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    scPharmaceuticals, Inc.
    Sponsor organisation address
    2400 District Ave, Suite 310, Burlington, MA, United States, 01803
    Public contact
    John Mohr, Pharm.D., FIDP, scPharmaceuticals, Inc., +1 (781) 301-722, jmohr@scpharma.com
    Scientific contact
    John Mohr, Pharm.D., FIDP, scPharmaceuticals, Inc., +1 (781) 301-7220, jmohr@scpharma.com
    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
    08 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of 80 mg of furosemide delivered by subcutaneous delivery in the abdominal area over 5 hours when compared to oral administration in patients with heart failure with chronic fluid overload.
    Protection of trial subjects
    This trial was conducted in compliance with ICH Good Clinical Practice guidelines and was approved by the relevant Institutional Review Board. An Informed Consent was collected from all the subjects in this study and their safety was monitored until the conclusion of the subject's participation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 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
    Netherlands: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    4
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was planned to enroll up to 10 subjects. Subsequently, 10 subjects were enrolled, all 10 subjects completed the study, and all 10 subjects were evaluable.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Subcutaneous
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Furosemide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    80 mg scFurosemide (8mg/mL) administered abdominally via standard s.c. infusion set with the use of a commercial infusion pump, over 5 hours (30mg in first hour followed by 12.5mg/hour over 4 hours)

    Arm title
    		 Oral
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Furosemide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral furosemide (80 mg tablet)

    Number of subjects in period 1
    		Subcutaneous Oral
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 10 10
    Age categorical
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.9 ± 8.6 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 8 8
    NYHA Class
    Units: Subjects
        Class I
    		 0 0
        Class II
    		 10 10
        Class III
    		 0 0
        Class IV
    		 0 0
    History of ischemic heart disease
    Units: Subjects
        Yes
    		 6 6
        No
    		 4 4
    BMI
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    		 27.5 ± 4.5 -

    End points

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    End points reporting groups
    Reporting group title
    Subcutaneous
    Reporting group description
    		 -

    Reporting group title
    Oral
    Reporting group description
    		 -

    Primary: Furosemide Plasma Concentration

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    End point title
    		 Furosemide Plasma Concentration [1]
    End point description
    End point type
    Primary
    End point timeframe
    30 Minutes after administration
    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: The study was not powered to analyze for a statistically significant difference between the groups. Hence a statistical analysis was not performed.
    End point values
    		 Subcutaneous Oral
    Number of subjects analysed
    10
    10
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    916 ± 302
    1745 ± 1227
    No statistical analyses for this end point

    Primary: Furosemide Plasma Concentration

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    End point title
    		 Furosemide Plasma Concentration [2]
    End point description
    End point type
    Primary
    End point timeframe
    60 minutes after administration
    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: The study was not powered to analyze for a statistically significant difference between the groups. Hence a statistical analysis was not performed.
    End point values
    		 Subcutaneous Oral
    Number of subjects analysed
    10
    10
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    2129 ± 445
    2620 ± 1346
    No statistical analyses for this end point

    Primary: Plasma Concentration over 1000 ng/ml

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    End point title
    		 Plasma Concentration over 1000 ng/ml [3]
    End point description
    End point type
    Primary
    End point timeframe
    Hours 2 - 5
    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: The study was not powered to analyze for a statistically significant difference between the groups. Hence a statistical analysis was not performed.
    End point values
    		 Subcutaneous Oral
    Number of subjects analysed
    10
    10
    Units: Subjects
    10
    1
    No statistical analyses for this end point

    Primary: Bioavailability

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    End point title
    		 Bioavailability [4]
    End point description
    End point type
    Primary
    End point timeframe
    8 Hours after administration
    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: The study was not powered to analyze for a statistically significant difference between the groups. Hence a statistical analysis was not performed.
    End point values
    		 Subcutaneous Oral
    Number of subjects analysed
    10
    10
    Units: percent
        number (not applicable)
    99.6
    61
    No statistical analyses for this end point

    Primary: Urine Output

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    End point title
    		 Urine Output [5]
    End point description
    End point type
    Primary
    End point timeframe
    8 hours
    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: The study was not powered to analyze for a statistically significant difference between the groups. Hence a statistical analysis was not performed.
    End point values
    		 Subcutaneous Oral
    Number of subjects analysed
    10
    10
    Units: millilitre(s)
        arithmetic mean (full range (min-max))
    1833 (1623 to 2726)
    1550 (1353 to 1866)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening to Study Completion
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Subcutaneous
    Reporting group description
    		 -

    Reporting group title
    Oral
    Reporting group description
    		 -

    Serious adverse events
    		 Subcutaneous Oral
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Subcutaneous Oral
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    0 / 10 (0.00%)
    Vascular disorders
    Stroke
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Bruise at Injection Site
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Exhausted
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Red discharge
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Burning/stinging sensation at/around injection site
         subjects affected / exposed
    4 / 10 (40.00%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Exacerbated COPD
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Cramps both legs
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Flu
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    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/30062191
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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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