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    Summary
    EudraCT Number:2019-003842-34
    Sponsor's Protocol Code Number:MK-5592-127
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-09-03
    Trial 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003842-34
    A.3Full title of the trial
    A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Posaconazole (MK-5592) IV and oral in children less than 2 years of age with invasive fungal infection
    A.3.2Name or abbreviated title of the trial where available
    Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFI
    A.4.1Sponsor's protocol code numberMK-5592-127
    A.5.4Other Identifiers
    Name:INDNumber:75,061; 125,097
    Name:EU CTNumber:2023-505613-24
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/101/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme LLC
    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 LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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® (posaconazole)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V
    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 Concentrate for solution for infusion
    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 INNPOSACONAZOLE
    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 number18
    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 No
    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 namePosaconazole
    D.3.2Product code MK-5592
    D.3.4Pharmaceutical form Powder for 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 number30
    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
    Invasive Fungal Infection
    E.1.1.1Medical condition in easily understood language
    Invasive 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
    1. To estimate the pharmacokinetics (PK) of posaconazole (POS) intravenous (IV) and powder for oral suspension (PFS) in participants <2 years of age (Panels A and B).
    E.2.2Secondary objectives of the trial
    1. To compare the exposures to POS in neonates and infants <2 years of age to those from adult and older pediatric population (Panel B only).
    2. To evaluate the safety and tolerability of POS in participants <2 years of age (Panels A and B separately).
    3. To evaluate all-cause mortality at Day 28 in participants treated with POS (Panel B only).
    4. To evaluate the need for additional antifungal therapy (Panel B only).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Panel A Participants Only
    1. Is undergoing treatment for possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (which can include candidiasis) per the modified 2008 EORTC/MSG consensus criteria

    Panel B Participants Only
    2. Has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (see Appendix 8 of the protocol for diagnostic guidance per the modified 2020 EORTC/MSG consensus criteria)

    Panel A and Panel B Participants
    3. Has a central line (eg, central venous catheter, peripherally inserted central catheter) in place or planned to be in place before beginning IV study intervention
    4. Is male or female, from birth to <2 years of age at the time of first dose of study intervention
    5. Has a body weight of ≥500 g
    6. The participant (or legally acceptable representative) has provided documented informed consent for the study
    E.4Principal exclusion criteria
    Panel A and B Participants
    1. Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
    2. Has known or suspected active COVID-19 infection.
    3. Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study
    intervention used
    4. Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
    5. Has any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

    Panel B Participants Only
    6. Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
    7. Has suspected/proven invasive candidiasis.

    Panel A Participants Only
    8. Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention

    Panel B Participants Only
    9. Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention.

    Panel A and Panel B Participants
    10. Has enrolled previously in the current study and been discontinued
    11. Has QTc prolongation (based on either Fridericia or Bazett's correction) at screening >500 msec
    12. Has significant liver dysfunction at screening, defined as:
    - Total bilirubin >1.5 × ULN and AST or ALT >3 × ULN with normal alkaline phosphatase
    13. Has calculated creatinine clearance <20 mL/min/1.73 m2 (modified Schwartz formula) at screening
    14. Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
    15. Has an immediate family member (eg, parent/legal guardian, sibling) who is investigational site or Sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Average concentration (Cavg) of single-dose IV POS (Panel A)
    2. Maximum concentration (Cmax) of single-dose IV POS (Panel A)
    3. Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)
    4. Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)
    5. Clearance (CL) of single-dose IV POS (Panel A)
    6. Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)
    7. Cavg of multiple-dose IV POS (Panel B)
    8. Cmax of multiple-dose IV POS (Panel B)
    9. Tmax of multiple-dose IV POS (Panel B)
    10. AUC0-24 of multiple-dose IV POS (Panel B)
    11. CL of multiple-dose IV POS (Panel B)
    12. AUC0-∞ of multiple-dose IV POS (Panel B)
    13. Cavg of multiple-dose PFS (Panel B)
    14. Cmax of multiple-dose PFS (Panel B)
    15. Tmax of multiple-dose PFS (Panel B)
    16. AUC0-24 of multiple-dose PFS (Panel B)
    17. CL of multiple-dose PFS (Panel B)
    18. AUC0-∞ of multiple-dose PFS (Panel B)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1 and Day 2
    2. Day 1 and Day 2
    3. Day 1 and Day 2
    4. Day 1 and Day 2
    5. Day 1 and Day 2
    6. Day 1 and Day 2
    7. Weeks 1, 2, 4, 6, 9, and 12
    8. Weeks 1, 2, 4, 6, 9, and 12
    9. Weeks 1, 2, 4, 6, 9, and 12
    10. Weeks 1, 2, 4, 6, 9, and 12
    11. Weeks 1, 2, 4, 6, 9, and 12
    12. Weeks 1, 2, 4, 6, 9, and 12
    13. Weeks 1, 2, 4, 6, 9, and 12
    14. Weeks 1, 2, 4, 6, 9, and 12
    15. Weeks 1, 2, 4, 6, 9, and 12
    16. Weeks 1, 2, 4, 6, 9, and 12
    17. Weeks 1, 2, 4, 6, 9, and 12
    18. Weeks 1, 2, 4, 6, 9, and 12
    E.5.2Secondary end point(s)
    1. Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B only)
    2. Percentage of participants with ≥1 adverse events (AEs) (Panels A and B)
    3. Percentage of participants with ≥1 drug-related AEs (Panels A and B)
    4. Percentage of participants discontinuing from study treatment due to AE(s) (Panels A and B)
    5. Percentage of participants with all-cause mortality through 28 days (Panel B)
    6. Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period [Panel B]
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1 and Day 2
    2. Up to 98 days
    3. Up to 98 days
    4. Up to 84 days
    5. Up to Day 28
    6. Up to 84 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 Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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-panel
    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 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Peru
    Israel
    Russian Federation
    United Kingdom
    United States
    Belgium
    Greece
    Poland
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 40
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 10
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 10
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 40
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-12
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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