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    Summary
    EudraCT Number:2007-004645-15
    Sponsor's Protocol Code Number:P03579
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-15
    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 number2007-004645-15
    A.3Full title of the trial
    Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia


    Additional PIP decision number: P/0141/2015
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children
    A.4.1Sponsor's protocol code numberP03579
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01716234
    A.5.4Other Identifiers
    Name:Merck Sharp & Dohme Corp. Number:MK-5592-032
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/041/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station
    B.5.3.3Post codeNJ 08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1(267) 305-3246
    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 Noxafil
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Oral suspension
    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 INNPOSACONAZOLE
    D.3.9.2Current sponsor codeMK-5592
    D.3.9.3Other descriptive namePOSACONAZOLE
    D.3.9.4EV Substance CodeSUB20322
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Treatment and prophylaxis of invasive fungal infections
    E.1.1.1Medical condition in easily understood language
    Fungal infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10017533
    E.1.2Term Fungal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with neutropenia or expected neutropenia aged 3 months to <18 years.
    E.2.2Secondary objectives of the trial
    - to evaluate the safety and tolerability of POS administered orally at three dosage levels to immunocompromised children with neutropenia or expected neutropenia aged 3 months to <18 years
    - to compare the exposures to POS in pediatric subjects to those from an adult population with similar underlying conditions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children of either sex and of any race, 3 months to <18 years of age.
    2. Subjects’ parent or legally authorized representative must be willing to give written informed consent. Assent will be obtained from minors according to institutional practices.
    3. Subjects must have documented or anticipated neutropenia (ANC ≤500/mm3 [0.5 x 109/L]) expected to last for at least 7 days and only in the following clinical situations:
    a. Acute leukemia (including new and relapse),
    b. Myelodysplasia,
    c. Severe aplastic anemia,
    d. Autologous HSCT recipients,
    e. High risk neuroblastoma,
    f. Advanced stage non-Hodgkin’s lymphoma,
    g. Recipients of allogeneic HSCT during the pre-engraftment period (neutropenia period).
    4. Male and female subjects of child-bearing potential must agree to use a medically accepted method of contraception throughout the study and for at least 30 days after stopping the medication, unless they are surgically or medically sterile or agree to abstain from sexual intercourse. Acceptable methods of contraception include 2 of the following:
    a. Condoms (male or female) with spermicide,
    b. Diaphragm or cervical cap (if acceptable according to local standard of care) with spermicide (females),
    c. Hormonal contraceptives or intrauterine device with spermicide (females).
    E.4Principal exclusion criteria
    1. Subjects with proven IFI, as defined by the MSG/EORTC criteria, prior to study entry.
    2. Subjects with Grade 3 or Grade 4 nausea and/or vomiting at Screening.
    3. Subjects who have received POS within the past 10 days prior to Screening.
    4. Subjects receiving prohibited drugs (Table 3).
    5. Subjects whose laboratory tests are outside normal limits, as follows:
    a. AST or ALT >5 times the upper limit of normal (ULN)
    b. Serum total bilirubin >2.5 x ULN
    c. Calculated creatinine clearance <30 mL/min.
    6. Subjects with QTc prolongation:
    a. Symptomatic QTc prolongation >450 msec (males) or >470 msec (females)
    b. Any QTc prolongation of >500 msec
    7. Subjects who are unable to receive study drug enterally.
    8. Female subjects who are pregnant, intend to become pregnant during the course of the study, or are breastfeeding.
    9. Subjects with a history of anaphylaxis attributed to the azole class of antifungal agents.
    10. Subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study, including receiving less than 7 days of POS.
    11. Subjects who have already participated in this study or are participating in any Phase 1 clinical study or any study for a medication that has not yet received regulatory approval.
    12. Subjects who are part of the study staff personnel or family members of the study staff personnel.
    E.5 End points
    E.5.1Primary end point(s)
    1. Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
    2. Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups) )
    2. Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose)
    E.5.2Secondary end point(s)
    1. Number of Participants With an Adverse Event
    2. Number of Participants With an Adverse Event Leading to Study Drug Discontinuation
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Day 58
    2. Up to Day 28
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerance
    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
    Safety, Tolerance, and 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 Yes
    E.8.1.7.1Other trial design description
    sequential dose-escalation
    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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years6
    E.8.9.2In all countries concerned by the trial months8
    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: 142
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 95
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 46
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 142
    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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