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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-002780-42
    Sponsor's Protocol Code Number:TR701-111
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-002780-42
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
    A.4.1Sponsor's protocol code numberTR701-111
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01156077
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTrius Therapeutics
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTrius Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrius Therapeutics
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address6310 Nancy Ridge Drive,
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number8584520370
    B.Sponsor: 2
    B.1.1Name of SponsorCubist Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCubist Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCubist Phamaceuticals, Inc
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address65 Hayden Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number781860-8660
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sivextro
    D.2.1.1.2Name of the Marketing Authorisation holderTrius Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTR-701 FA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSivextro
    D.3.9.3Other descriptive nameTR-701 FA
    D.3.9.4EV Substance CodeSUB32991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sivextro
    D.2.1.1.2Name of the Marketing Authorisation holderTrius Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTR-701 FA
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSivextro
    D.3.9.3Other descriptive nameTR-701 FA
    D.3.9.4EV Substance CodeSUB32991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute bacterial skin and skin structure infections
    E.1.1.1Medical condition in easily understood language
    Skin infection
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10040879
    E.1.2Term Skin investigations
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the single-dose PK of TR-701 FA and its active metabolite, TR-700, when administered orally in 12- to 17-year-old adolescent patients
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of oral TR-701 FA administration in 12- to 17-year-old adolescent patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who met the following criteria were eligible to be included in the study:
    1. males and females, between 12 and 17 years of age, inclusive
    2. receiving prophylaxis for or had a confirmed or suspected infection with
    gram-positive bacteria and receiving concurrent antibiotic treatment with
    gram-positive antibacterial activity
    3. patient’s weight >5th percentile and <95th percentile for his or her age
    4. in stable condition as determined from medical history, physical examination,
    12-lead ECG, vital signs, and clinical laboratory evaluations (if the results of the
    chemistry, hematology, or urinalysis (UA) tests were outside normal reference
    ranges for a patient’s age, the patient could have been included if the Investigator
    judged the abnormalities or deviations from normal as not clinically significant or
    as related to infection. This determination was recorded in the patient’s source
    documents and initialed by the Investigator)
    5. no clinically significant ECG abnormalities in the judgment of the Investigator
    6. serum creatinine within ±10% of the normal range for the patient’s age
    7. females were premenarchal, surgically sterile, abstinent, or practicing an effective
    method of birth control (eg, a nonhormonal intrauterine device [IUD] with
    spermicide; female condom with spermicide; contraceptive sponge with
    spermicide; diaphragm with spermicide; cervical cap with spermicide; a male
    sexual partner who agreed to use a male condom with spermicide; a sterile sexual
    partner; or prescription oral contraceptives in addition to another approved
    method) before entry and throughout the study
    8. females had a negative FDA-approved urine or blood β-human chorionic
    gonadotropin pregnancy test at Screening
    9. males were either surgically sterile, abstinent, or practicing an effective method of
    birth control (eg, double-barrier method; female partner sterilization; female
    partner use of prescription oral contraceptives, contraceptive injections, IUD,
    contraceptive patch) throughout the study
    10. no history of human immunodeficiency virus infection or acquired
    immunodeficiency syndrome
    11. patients were willing to adhere to the prohibitions and restrictions specified in the
    protocol
    12. parents or patients’ legally acceptable representative(s) signed an informed
    consent document indicating that they understood the purpose of and procedures
    required for the study and were willing to have their child participate in the study.
    Assent was also required of children capable of understanding the nature of the
    study (typically ≥7 years of age)
    E.4Principal exclusion criteria
    Patients who had any of the following criteria were to be excluded from the study:
    1. relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis,
    moderate or severe renal impairment, or any physical condition that could have
    interfered with the interpretation of the study results
    2. any acute or chronic condition that, in the opinion of the Investigator, would have
    limited the patient’s ability to complete and/or participate in this clinical study
    3. physician-diagnosed migraine headaches
    4. history of infection with hepatitis or other significant hepatic disease
    5. relevant history of drug allergy or hypersensitivity to oxazolidinones
    6. liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST],
    bilirubin) more than 2 times upper limit of normal (ULN)
    7. females who were pregnant or breast feeding
    8. hormonal implantable, transdermal, or intravaginal (eg, etonogestrel/ethinyl
    estradiol vaginal ring) contraceptives could not have been used from 14 days prior
    to enrollment until 30 days after Final Visit. Injectable contraceptives were not
    permitted from 90 days prior to enrollment until 30 days after Final Visit
    9. significant blood loss (300 mL or 5% of total blood volume) within 60 days before
    Screening
    10. known or suspected hypersensitivity or intolerance to heparin, if an indwelling
    catheter (eg, heparin lock) was used
    11. any history of drug or alcohol abuse
    12. consumption of alcohol-, grapefruit-, caffeine-(excluding regular soda or soft-drinks
    but including coffee and energy drinks), or high tyramine-containing foods or
    beverages from 24 hours before study drug administration until the last assessment
    13. receiving chronic systemic immunosuppressive therapy such as chemotherapy for
    cancer or prednisone doses ≥20 mg per day for ≥3 of the last 12 months
    14. patients who had received an experimental drug or used an experimental medical
    device within 30 days or 5 half-lives before Screening
    15. use of rifampin, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants,
    buspirone, meperidine, selective serotonin reuptake inhibitors (SSRIs), and
    serotonin 5-HT1 receptor agonists (triptans) within 14 days prior to dosing
    16. use of the following medications within 48 hours before dosing, or planned use
    through Final Visit: directly or indirectly acting sympathomimetic agents (eg,
    pseudoephedrine, phenylpropanolamine), vasopressive agents (eg, epinephrine,
    norepinephrine), dopaminergic agents (eg, dopamine, dobutamine), or
    over-the-counter medications containing vasoconstrictive agents; however, use of a
    local, cutaneously injected anesthetic containing a small amount of epinephrine was
    allowed
    17. use of probenecid (all patients) and ranitidine, cimetidine, and antacids for patients
    in Part A (oral dose) from 24 hours prior to dosing and throughout the study
    18. children of the Investigator or of employees of the Investigator or Study Center
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic Parameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 days
    E.5.2Secondary end point(s)
    Adverse Event Reporting
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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