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    Summary
    EudraCT Number:2008-008228-34
    Sponsor's Protocol Code Number:DPM-PK-102
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-29
    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
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-008228-34
    A.3Full title of the trial
    Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients
    A.4.1Sponsor's protocol code numberDPM-PK-102
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPharmaxis Ltd
    B.1.3.4CountryAustralia
    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 support
    B.4.2Country
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/325
    D.3 Description of the IMP
    D.3.1Product nameIDPM: Inhaled Dry Powder Mannitol
    D.3.2Product code IDPM
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMANNITOL
    D.3.9.1CAS number 69658
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Cystic Fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients. The specific objectives are as follows:

    Primary Objectives-

    • Determine the pharmacokinetic parameters of mannitol in adult and paediatric CF patients after a single dose of IDPM
    • Determine the pharmacokinetic parameters of mannitol in adult and paediatric CF patients after twice daily dosing of IDPM for 5 days
    • Compare PK of mannitol in adult and paediatric CF patients after single and multiple dosing of IDPM.
    E.2.2Secondary objectives of the trial
    • Clinical safety of IDPM in adult and paediatric CF patients after single and multiple dosing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Have given written informed consent to participate in this study in
    accordance with local regulations
    • Have a confirmed diagnosis of cystic fibrosis (sweat test and/or genotype)
    • Be aged >6 years (6–11 for paediatrics, 12–17 for adolescents and greater than or equal to 18 years for adults)
    • Have FEV1 > 30 % and < 90% predicted
    E.4Principal exclusion criteria
    • Be investigators, site personnel directly affiliated with this study, or their
    immediate families. Immediate family is defined as a spouse, parent, child
    or sibling, whether biologically or legally adopted.
    • Be considered “terminally ill” or listed for lung transplantation
    • Have had a lung transplant
    • Be using nebulised hypertonic saline
    • Have had a significant episode of haemoptysis (> 60 mL) in the three
    months prior to enrolment
    • Have had a myocardial infarction in the three months prior to enrolment
    • Have had a cerebral vascular accident in the three months prior to
    enrolment
    • Have had major ocular surgery in the three months prior to enrolment
    • Have had major abdominal, chest or brain surgery in the three months prior
    to enrolment
    • Have a known cerebral, aortic or abdominal aneurysm
    • Be breast feeding or pregnant, or plan to become pregnant while in the
    study
    • Be using an unreliable form of contraception (female patients at risk of
    pregnancy only)
    • Be participating in another investigative drug study, parallel to, or within 4
    weeks of study entry (except inhaled mannitol)
    • Not able to maintain a mannitol free diet from Day -2 until Day 8 of the
    treatment phase.
    • Have a known allergy to mannitol
    • Be using beta blockers
    • Have uncontrolled hypertension – systolic blood pressure > 190 and / or
    diastolic blood pressure > 100
    • Have a condition or be in a situation which in the Investigator’s opinion
    may put the subject at significant risk, may confound results or may
    interfere significantly with the patient’s participation in the study
    • Be MTT positive.
    E.5 End points
    E.5.1Primary end point(s)
    The following PK endpoints will be calculated for the completed subjects:
    • Day 1 and 2 (pre-dose Day 1 to 24 h post-dose):
    Cmax, tmax, AUC0-12h, AUC0-infinity, kel, t½, C12h
    • Day 7 and 8 (pre-dose Day 1 to 24 h post-dose):
    Cmax, tmax, AUC0-12h, kel, t½, Cpre-dose, C12h

    Safety Endpoints:

    • serious adverse events,
    • treatment related adverse events (defined as being possibly, probably or
    definitely related to treatment in the opinion of the investigator),
    • treatment related serious adverse events,
    • adverse events leading to study withdrawal,
    • treatment related adverse events leading to study withdrawal, and
    • deaths
    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 Information not present in EudraCT
    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 No
    E.7.1.3.1Other trial type description
    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 Yes
    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.8.3 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 No
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children from 6 years old. Consent will be sought from a legally authorised representative, and assent will be sought from children aged 8 and above. An age appropriate explanation of the study will be given to all children.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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 Decision2009-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-08
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