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    Summary
    EudraCT Number:2016-000309-34
    Sponsor's Protocol Code Number:7654321
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-000309-34
    A.3Full title of the trial
    Vorapaxar in the human endotoxemia model
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vorapaxar in LPS induced acute inflammatory states in healthy volunteers
    A.3.2Name or abbreviated title of the trial where available
    LPS_Vorapaxar
    A.4.1Sponsor's protocol code number7654321
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFWF-SFB54
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointDept. of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004314040029810
    B.5.5Fax number004314040029990
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    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 Zontivity
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Corp.
    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.3.1Product nameVorapaxar
    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 INNVorapaxar
    D.3.9.1CAS number 618385-01-6
    D.3.9.2Current sponsor codeVorapaxar
    D.3.9.3Other descriptive nameVORAPAXAR
    D.3.9.4EV Substance CodeSUB88191
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5mg
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    LPS induced acute inflammatory state in healthy volunteers
    E.1.1.1Medical condition in easily understood language
    LPS infusion leads to an acute, transient inflammatory state in otherwise healthy volunteers
    E.1.1.2Therapeutic area Not possible to specify
    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 investigate whether vorapaxar reduces LPS induced coagulation activation assessed by prothrombin fragments F1+2
    E.2.2Secondary objectives of the trial
    to investigate whether vorapaxar reduces LPS induced:
    - coagulation activation and fibrinolysis (TAT, DDimer, PAP, etc.)
    - platelet activation and aggregation (PF4, Whole blood aggregometry, Verify now, etc.)
    - endothelial activation (vWF activity, endothelial glycocalyx thickness etc.)
    - cell counts and subsets of monocytes
    effects of endotoxemia on:
    platelet proteasome, neutrophil patterns (facs), platelet activation and LPS washout effects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥18 years of age
    • ≥60 kg bodyweight
    • Normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant
    • Normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant
    • Willingness to comply with the trial’s safety demands (to refrain from excessive sporting activities two weeks after Vorapaxar intake, i.e. full contact sports, climbing, mountain biking etc.)
    • Ability to understand the purpose and nature of the study, as well as the associated risks
    • No planned surgeries or other medical interventions in the planned study period
    E.4Principal exclusion criteria
    • Intake of any drugs that may interfere with the trial’s endpoints or drugs (i.e. platelet inhibitors, anticoagulants, CYP3A4 inhibitors, NSAIDs, SSRI, SNRI)
    • Positive results of HIV or hepatitis virology
    • Acute illness with systemic inflammatory reactions
    • Known allergies, hypersensitivities or intolerances to any of the used substances
    • Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator
    • History of stroke, transient ischemic attacks or intracerebral hemorrhage
    • Known coagulation or platelet disorders
    • Participation in an LPS trial within 6 weeks of the first study day
    • Severe liver or kidney dysfunction
    E.5 End points
    E.5.1Primary end point(s)
    prothrombin fragments F1+2
    E.5.1.1Timepoint(s) of evaluation of this end point
    repeated measures between two study periods (placebo vs. vorapaxar, crossover study)
    two to four hours after lps bolus usually highest values of prothrombin fragments F1+2 are measured. Thus, main effects will be measured at that time point.
    E.5.2Secondary end point(s)
    -coagulation activation and fibrinolysis (TAT, PAP, tpa, thrombelastometry etc.)
    - platelet activation and aggregation (PF4, Whole blood aggregometry, Verify now, proteasome etc.)
    - inflammation and endothelial activation (endothelial glycocalyx, vWF, etc., TSP-1)
    - cell counts and monocyte/neutrophil subsets
    E.5.2.1Timepoint(s) of evaluation of this end point
    -24h as baseline
    0h before LPS, but 24h after vorapaxar
    1h
    1,5h
    2h
    4h
    6h
    8h
    24h after LPS infusion
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    last follow up visit of last participant
    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 months6
    E.8.9.1In the Member State concerned 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: 16
    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 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.4.1In the member state16
    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)
    Not applicable as no indication for vorapaxar exists, any necessary post-treatment medical attention will be available for all participants.
    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 Decision2016-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-30
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