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    Clinical Trial Results:
    A phase 1, open-label, multi-centre study to determine the PK and safety of solithromycin as add-on therapy in adolescents with suspected or confirmed bacterial infection.

    Summary
    EudraCT number
    		 2014-004037-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2016
    First version publication date
    21 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CE01-119
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01966055
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cempra Pharmaceuticals
    Sponsor organisation address
    6320 Quadrangle Drive, Suite 360, Chapel Hill, United States, 27517
    Public contact
    Clinical Trials Info, Cempra Pharmaceuticals, clinicaltrials@cempra.com
    Scientific contact
    Clinical Trials Info, Cempra Pharmaceuticals, clinicaltrials@cempra.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001581-PIP01-13
    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
    28 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine the PK profile of a 5-day oral dosing regimen of solithromycin
    Protection of trial subjects
    Solithromycin was administered orally based on weight as add-on to antimicrobial agents administered per routine standard of care to adolescents with a suspected or confirmed infection.
    Background therapy
    		 The most frequently used concomitant medications included sulfamethoxazole with trimethoprim, ibuprofen, ketorolac, metronidazole, multivitamins, paracetamol, and zinc sulphate.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    31 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    0
    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)
    13
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled from 6 study sites in United States.

    Pre-assignment
    Screening details
    		 1. Male or female 12 to 17 years of age (inclusive) 2. Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active 3. No evidence or history of clinically significant medical condition 4. No diagnosis of bacterial meningitis 5.Serum creatinine < 2 mg/dL 6. Mean screening ECG QTcF < 450 ms

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

    Arms
    Arm title
    		 All subjects
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solithromycin
    Investigational medicinal product code
    CEM-101
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Day 1: 12 mg/kg (not to exceed 800 mg) Day 2: 6 mg/kg (not to exceed 400 mg/day) The median (range) dose on Day 1 was 800 mg (400-800 mg) and on Days 2-5 was 400 mg (200-400 mg).

    Number of subjects in period 1
    		All subjects
    Started
    13
    Completed
    13

    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
    		 13 13
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 13 13
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 15.2 (12 to 17) -
    Gender categorical
    Units: Subjects
        male
    		 10 10
        female
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Subject analysis set title
    All patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients enrolled in the study.

    Primary: Cmin Day1

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    End point title
    		 Cmin Day1 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint..
    End point values
    		 All patients
    Number of subjects analysed
    13
    Units: microgram(s)/millilitre
        arithmetic mean (standard deviation)
    0.12 ± 0.11
    No statistical analyses for this end point

    Primary: Cmax Day1

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    End point title
    		 Cmax Day1 [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1
    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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    13
    Units: microgram(s)/millilitre
        arithmetic mean (standard deviation)
    0.97 ± 0.73
    No statistical analyses for this end point

    Primary: Tmax Day 1

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    End point title
    		 Tmax Day 1 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Day1
    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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    13
    Units: hour
        arithmetic mean (standard deviation)
    3.5 ± 2.1
    No statistical analyses for this end point

    Primary: AUC0-24 Day1

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    End point title
    		 AUC0-24 Day1 [4]
    End point description
    End point type
    Primary
    End point timeframe
    Day1
    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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    12
    Units: microgram(s)/millilitre x h
        arithmetic mean (standard deviation)
    11.62 ± 8.55
    No statistical analyses for this end point

    Primary: AUC0-infinity Day1

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    End point title
    		 AUC0-infinity Day1 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Day1
    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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    7
    Units: microgram(s)/millilitre x h
        arithmetic mean (standard deviation)
    14.03 ± 10.68
    No statistical analyses for this end point

    Primary: Cmin Days 3-5

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    End point title
    		 Cmin Days 3-5 [6]
    End point description
    End point type
    Primary
    End point timeframe
    Days 3-5
    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: The PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    13
    Units: microg/mL
        arithmetic mean (standard deviation)
    0.06 ± 0.08
    No statistical analyses for this end point

    Primary: Cmax Days 3-5

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    End point title
    		 Cmax Days 3-5 [7]
    End point description
    End point type
    Primary
    End point timeframe
    Days 3-5
    Notes
    [7] - 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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint..
    End point values
    		 All patients
    Number of subjects analysed
    13
    Units: microgram(s)/millilitre
        arithmetic mean (standard deviation)
    0.74 ± 0.61
    No statistical analyses for this end point

    Primary: AUC0-24 Days 3-5

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    End point title
    		 AUC0-24 Days 3-5 [8]
    End point description
    End point type
    Primary
    End point timeframe
    Days 3-5
    Notes
    [8] - 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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint..
    End point values
    		 All patients
    Number of subjects analysed
    10
    Units: microgram(s)/millilitre x h
        arithmetic mean (standard deviation)
    9.28 ± 6.3
    No statistical analyses for this end point

    Primary: AUC0-infinity Days 3-5

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    End point title
    		 AUC0-infinity Days 3-5 [9]
    End point description
    End point type
    Primary
    End point timeframe
    Days 3-5
    Notes
    [9] - 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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    10
    Units: microgram(s)/millilitre x h
        arithmetic mean (standard deviation)
    10 ± 7
    No statistical analyses for this end point

    Primary: Tmax Days 3-5

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    End point title
    		 Tmax Days 3-5 [10]
    End point description
    End point type
    Primary
    End point timeframe
    Days 3-5
    Notes
    [10] - 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 PK evaluation was done using a noncompartmental PK analysis (WinNonLin software version 6.3, Pharsight Corporation). There is no formal statistical analysis for this endpoint.
    End point values
    		 All patients
    Number of subjects analysed
    13
    Units: hour
        arithmetic mean (standard deviation)
    3 ± 1.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first study drug administration to late follow-up visit (Day 14 +/-4).
    Adverse event reporting additional description
    Every effort have been made to bring the patient back to collect concomitant medications, adverse events (AEs), and laboratory tests. If the patient was unable or unwilling to return, the concomitant medications and AEs were collected via telephone.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 All patients who received at least 1 dose of study drug.

    Serious adverse events
    		 Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Abcess limb
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 13 (61.54%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Vascular disorders
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 13 (23.08%)
         occurrences all number
    3
    General disorders and administration site conditions
    Catheter site rash
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Middle ear effusion
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    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
    For support, Contact us.
    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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