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    Summary
    EudraCT Number:2013-002557-30
    Sponsor's Protocol Code Number:PRO/GLY/001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-03-18
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-002557-30
    A.3Full title of the trial
    A two-staged, open label, single dose, two period, two-sequence,
    crossover study to compare the bioavailability of 2 mg Glycopyrronium
    Bromide from a new oral solution (2 mg/5 ml) (Test Product) with that
    of 2 mg Glycopyrronium Bromide from Cuvposa (1 mg/5 ml) Solution
    (Reference product) in at least 36 healthy male and female subjects
    under fasting conditions.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A two-staged, open label, single dose, two period, two-sequence,
    crossover study to compare the bioavailability of 2 mg Glycopyrronium
    Bromide from a new oral solution (2 mg/5 ml) (Test Product) with that
    of 2 mg Glycopyrronium Bromide from Cuvposa (1 mg/5 ml) Solution
    (Reference product) in at least 36 healthy male and female subjects
    under fasting conditions.
    A.4.1Sponsor's protocol code numberPRO/GLY/001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/158/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorProveca Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportProveca Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProveca Ltd
    B.5.2Functional name of contact pointDr. Helen Shaw
    B.5.3 Address:
    B.5.3.1Street AddressDaresbury Innovation Centre, Keckwick Lane
    B.5.3.2Town/ cityDaresbury, Halton
    B.5.3.3Post codeWA4 4FS
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailinfo@proveca.co.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Cuvposa
    D.2.1.1.2Name of the Marketing Authorisation holderMerz 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.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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 nameGlycopyrronium Bromide Oral Solution (2 mg/5 ml)
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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
    Sialorrhoea (chronic pathological drooling)
    E.1.1.1Medical condition in easily understood language
    Excessive production of saliva (drooling)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine and compare the pharmacokinetics (primary variables; AUC0-t, AUC¬0-∞,, Cmax, tmax and t1/2) from the new oral solution of glycopyrronium bromide with glycopyrronium bromide from Cuvposa®.
    E.2.2Secondary objectives of the trial
    Evaluate the taste acceptability including sweet or bitter-tasting, granular or smooth in texture and of pleasant or unpleasant flavour of glycopyrronium bromide oral solution.

    Evaluate adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy volunteers:
    • Age: ≥ 18 to ≤ 50 years
    • Sex: Male or female
    • Status: Healthy volunteers with a body mass index of ≥20, ≤30kg/m2
    • Subjects who give written informed consent
    E.4Principal exclusion criteria
    • Known allergy to glycopyrronium bromide or any of the excipients.
    • Refusal to give informed consent
    • Pregnancy
    • Use of glycopyrronium bromide liquid within approximately 24 hours prior to baseline
    • Use of any of the prohibited anticholinergic or cholinergic medications specified in the protocol within three plasma half-lives of the medication prior to baseline
    • Medical conditions contraindicating anticholinergic therapy including: Glaucoma, obstructive uropathy, uretovesicular reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant ECG abnormalities as determined by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    To determine and compare the pharmacokinetics (primary variables; AUC0-t, AUC¬0-∞,, Cmax, tmax and t1/2) from the new oral solution of glycopyrronium bromide with glycopyrronium bromide from Cuvposa®.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Potential participants will be screened and eligible subjects scheduled to commence treatment visits within 2 weeks of screening. Subjects to be randomised to one of two sequence (R-T or T-R), with 7 days between doses (R=Reference, T=Test). Dosing to take place in the morning after admission, with venous blood samples being drawn pre-dose and at 5, 10, 20, 30, 45, 60 minutes post-dose and 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
    E.5.2Secondary end point(s)
    Evaluate the taste acceptability including sweet or bitter-tasting, granular or smooth in texture and of pleasant or unpleasant flavour of glycopyrronium bromide oral solution.

    Evaluate adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Taste acceptability endpoint: assessed on the day of dosing.

    Adverse events: monitored for the duration of the trial.
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    South Africa
    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 years0
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    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 Yes
    F.3.2Patients No
    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 36
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Parexel
    G.4.3.4Network Country South Africa
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: South Africa
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