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    Clinical Trial Results:
    A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients

    Summary
    EudraCT number
    		 2015-002780-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Sep 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 May 2016
    First version publication date
    02 Aug 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    1986-026
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01156077
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Trius Therapeutics
    Sponsor organisation address
    6310 Nancy Ridge Drive, San Diego, United States,
    Public contact
    Medical Director, Trius Therapeutics, 011 8584520370,
    Scientific contact
    Medical Director, Trius Therapeutics, 011 8584520370,
    Sponsor organisation name
    Cubist Pharmaceuticals, Inc
    Sponsor organisation address
    65 Hayden Avenue, Lexington, United States,
    Public contact
    Medical Director, Cubist Pharmaceuticals, Inc, 011 781860-8660,
    Scientific contact
    Medical Director, Cubist Pharmaceuticals, Inc, 011 781860-8660,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jul 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Sep 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the single-dose pharmacokinetics (PK) of TR-701 free acid (FA) and its active metabolite, TR-700, when administered orally and intravenously (IV) in 12- to 17-year-old adolescent subjects
    Protection of trial subjects
    This study was conducted in accordance with current United States Food and Drug Administration regulations, International Conference of Harmonisation Good Clinical Practice guidelines, and the Institutional Review Board and local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 2010
    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
    United States: 20
    Worldwide total number of subjects
    20
    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)
    20
    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
    		 -

    Pre-assignment
    Screening details
    		 Eligible subjects in the study were to be 12- to 17-year-old adolescents who were receiving prophylaxis for or who had a confirmed or suspected gram-positive bacterial infection and were receiving concurrent antibiotic treatment with gram-positive antibacterial activity.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 oral TR-701 FA
    Arm description
    		 Single oral dose of 200 milligrams (mg) TR-701 free acid (FA)
    Arm type
    		 Experimental

    Investigational medicinal product name
    TR-701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose of 200-milligrams (mg) TR-701 free acid (FA) administered as an oral tablet

    Arm title
    		 IV TR-701 FA
    Arm description
    		 Single IV infusion of 200 mg TR-701 FA
    Arm type
    		 Experimental

    Investigational medicinal product name
    TR-701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV infusion of 200 mg TR-701 FA

    Number of subjects in period 1
    		oral TR-701 FA IV TR-701 FA
    Started
    10
    10
    Received at least 1 dose of study drug
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    oral TR-701 FA
    Reporting group description
    		 Single oral dose of 200 milligrams (mg) TR-701 free acid (FA)

    Reporting group title
    IV TR-701 FA
    Reporting group description
    		 Single IV infusion of 200 mg TR-701 FA

    Reporting group values
    		 oral TR-701 FA IV TR-701 FA Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
    Age continuous
    There was 1 subject in the IV TR-701 FA treatment group who as 11 years-old at the time of initial enrollment but 12 years old at the time of study drug administration. This subject is reported as 12 years old in the IV TR-701 FA treatment group.
    Units: years
        arithmetic mean (full range (min-max))
    		 15 (12 to 17) 14 (12 to 17) -
    Gender categorical
    Units: Subjects
        Female
    		 1 3 4
        Male
    		 9 7 16

    End points

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    End points reporting groups
    Reporting group title
    oral TR-701 FA
    Reporting group description
    		 Single oral dose of 200 milligrams (mg) TR-701 free acid (FA)

    Reporting group title
    IV TR-701 FA
    Reporting group description
    		 Single IV infusion of 200 mg TR-701 FA

    Primary: Mean and standard deviation (SD) Plasma Pharmacokinetic Parameter Data for TR-701: Cmax

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    End point title
    		 Mean and standard deviation (SD) Plasma Pharmacokinetic Parameter Data for TR-701: Cmax
    End point description
    Cmax=maximum observed plasma concentration ng/mL=nanograms per milliliter
    End point type
    Primary
    End point timeframe
    Two days
    End point values
    		 oral TR-701 FA IV TR-701 FA
    Number of subjects analysed
    10 [1]
    10 [2]
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax
    2231 ( 549 )
    3854 ( 1506 )
    Notes
    [1] - Subjects who received at least 1 dose of study drug with evaluable PK data
    [2] - Subjects who received at least 1 dose of study drug with evaluable PK data
    Statistical analysis title
    		 Statistical Analysis of TR-700 PK Data--Cmax
    Statistical analysis description
    Ratio of parameter means for natural log transformed parameter (expressed as a percent). Natural log transformed ratios transformed back to the linear scale. 90% confidence interval for ratio of parameter means of natural log transformed parameter (expressed as a percent). Natural log transformed confidence limits transformed back to the linear scale
    Comparison groups
    oral TR-701 FA v IV TR-701 FA
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Ratio of parameter means for natural log
    Point estimate
    59.34
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 47.5
         upper limit
    		 74.12
    Notes
    [3] - Analysis of variance (ANOVA)

    Primary: Mean (SD) Plasma Pharmacokinetic Parameter Data for TR-701: AUC (0-∞)

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    End point title
    		 Mean (SD) Plasma Pharmacokinetic Parameter Data for TR-701: AUC (0-∞)
    End point description
    AUC (0-∞)=area under the plasma concentration-time curve extrapolated to infinity ng*hr/mL=nanograms times hours per milliliter
    End point type
    Primary
    End point timeframe
    Two days
    End point values
    		 oral TR-701 FA IV TR-701 FA
    Number of subjects analysed
    10 [4]
    10 [5]
    Units: ng*hr/mL
    arithmetic mean (standard deviation)
        AUC(0- ∞)
    25205 ( 9153 )
    27820 ( 7282 )
    Notes
    [4] - Subjects who received at least 1 dose of study drug with evaluable PK data
    [5] - Subjects who received at least 1 dose of study drug with evaluable PK data
    Statistical analysis title
    		 Statistical Analysis of TR-700 PK Data--AUC (0 -∞)
    Statistical analysis description
    Ratio of parameter means for natural log transformed parameter (expressed as a percent). Natural log transformed ratios transformed back to the linear scale. 90% confidence interval for ratio of parameter means of natural log transformed parameter (expressed as a percent). Natural log transformed confidence limits transformed back to the linear scale.
    Comparison groups
    oral TR-701 FA v IV TR-701 FA
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Ratio of parameter means for natural log
    Point estimate
    88.83
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 70.37
         upper limit
    		 112.11
    Notes
    [6] - analysis of variance (ANOVA)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening (Study Day -3 to 1) through the Final Visit (Study Day 2)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    IV TR-701 FA
    Reporting group description
    		 -

    Reporting group title
    oral TR-701 FA
    Reporting group description
    		 -

    Serious adverse events
    		 IV TR-701 FA oral TR-701 FA
    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
    		 IV TR-701 FA oral TR-701 FA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    1 / 10 (10.00%)
    Investigations
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    PROCEDURAL PAIN
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    INFUSION SITE EXTRAVASATION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    CONSTIPATION
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    RASH
         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
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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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