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    Summary
    EudraCT Number:2014-004350-34
    Sponsor's Protocol Code Number:MK-5348-040
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-10-29
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004350-34
    A.3Full title of the trial
    A Comparative Bioavailability Study of a Tablet versus an Investigational
    Oral Suspension of Vorapaxar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Pediatric Formulation (liquid) to Adult Formulation
    (tablets)
    A.3.2Name or abbreviated title of the trial where available
    PK of Pediatric Formulation
    A.4.1Sponsor's protocol code numberMK-5348-040
    A.5.4Other Identifiers
    Name:CRO numberNumber:2014-3621
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/222/2014
    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.
    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.
    B.5.2Functional name of contact pointClinical Monitor
    B.5.3 Address:
    B.5.3.1Street Address351 North Sumneytown Pike
    B.5.3.2Town/ cityNorth Wales, PA
    B.5.3.3Post code19454
    B.5.3.4CountryUnited States
    B.5.6E-mailmartin_behm@merck.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVorapaxar
    D.3.2Product code MK-5348
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.3Other descriptive nameVORAPAXAR SULPHATE
    D.3.9.4EV Substance CodeSUB119537
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2085
    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 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 Zontivity
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME
    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.3.1Product nameZontivity™
    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.3.9.3Other descriptive nameVORAPAXAR SULPHATE
    D.3.9.4EV Substance CodeSUB119537
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.08
    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
    Vorapaxar is indicated for the reduction of thrombotic cardiovascular
    events in patients with a history of myocardial infarction (MI) or with
    peripheral
    arterial disease (PAD).
    E.1.1.1Medical condition in easily understood language
    Blood clots
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10014501
    E.1.2Term Embolism - blood clot
    E.1.2System Organ Class 100000004866
    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 comparative bioavailability between:
    • MK-5348 (vorapaxar) 0.2085 mg/mL oral suspension from Merck
    Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA; and
    • MK-5348 (Zontivity™) 2.08 mg tablet (equivalent to 2.5 mg
    vorapaxar sulfate) from Merck Sharp & Dohme Corp., a subsidiary of
    Merck & Co., Inc., USA; after a single-dose in healthy subjects under
    fasting conditions.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Healthy, non-smoking, male and female subjects, from 18 to 55
    years of age.
    2) BMI ≥ 19.0 and ≤30.0 kg/m2 and weight ≥60 kg.
    3) No clinically significant findings in vital-signs measurements.
    4) No clinically significant abnormal laboratory values.
    5) No clinically significant findings in a 12-lead electrocardiogram
    (ECG).
    6) Have no significant diseases.
    7) Willing to use an acceptable, effective method of contraception.
    8) Be informed of the nature of the study and give written consent
    prior to any study procedure.
    9) Have no clinically significant findings from a physical examination.
    E.4Principal exclusion criteria
    1) Known history or presence of any clinically significant medical
    condition.
    2) Known or suspected carcinoma.
    3) History of stroke, myocardial infarction (MI), transient ischemic
    attack (TIA), peripheral arterial disease (PAD) or intracranial
    hemorrhage (ICH).
    4) Known history or presence of active clinically
    significant/pathological bleeding (e.g., peptic ulcer, intracranial
    hemorrhage, clotting disorders).
    5) Known history or presence of galactose or fructose intolerance,
    sucrase-isomaltase insufficiency, Lapp lactase insufficiency,
    galactosemia, or glucose-galactose malabsorption syndrome.
    6) Subjects with mouth piercings, dentures, braces, dental appliances,
    or any other alteration to the mouth that may compromise drug
    delivery.
    9) Presence of clinically significant gastrointestinal disease or history
    of malabsorption within the last year.
    10) Presence of a medical condition requiring regular medication
    (prescription and/or over-the-counter) with systemic absorption.
    11) History of drug or alcohol addiction requiring treatment.
    12) Positive test result for HIV, Hepatitis B surface antigen or Hepatitis
    C antibody.
    13) Positive test result for urine drugs of abuse (cannabinoids, opiates,
    amphetamines, cocaine, phencyclidine, tricyclic antidepressants,
    barbiturates, methadone and benzodiazepines) or urine cotinine.
    14) Difficulty fasting or consuming standard meals.
    15) Does not tolerate venipuncture.
    16) Use of tobacco or nicotine-containing products within 6 months
    prior to drug administration.
    17) On a special diet within 30 days prior to drug administration (e.g.,
    liquid, protein, raw food diet).
    18) Participated in a clinical trial, which involved administration of an
    investigational medicinal product within 30 days prior to drug
    administration, or recently participated in a clinical investigation that,
    in the opinion of the Investigator, would jeopardize subject safety or
    the integrity of the study results.
    19) Donation or loss of whole blood (including clinical trials):
    • ≥ 50 mL and ≤ 499 mL within 30 days prior to drug administration;
    • ≥ 500 mL within 56 days prior to drug administration.
    20) Females who:
    • Have used oral or transdermal hormonal contraceptives within 21
    days prior to drug administration;
    • Have used implanted, injected, intravaginal or intrauterine hormonal
    contraceptives within 6 months prior to drug administration;
    • Are pregnant (serum hCG consistent with pregnancy); or
    • Are lactating.
    21) Have had a tattoo or body piercing within 30 days prior to drug
    administration.
    22) Estimated creatinine clearance of ≤80 mL/min based on the
    Cockcroft-Gault equation.
    23) Known history or presence of hypersensitivity or idiosyncratic
    reaction to vorapaxar (MK-5348) or any other drug substances with
    similar activity.
    24) Subject is mentally or legally incapacitated, has significant
    emotional problems at the time of screening or expected during the
    conduct of the study or has a history of a clinically significant
    psychiatric disorder over the last 5 years. Subjects who have had
    situational depression may be enrolled in the study at the discretion of
    the investigator.
    25) Have planned a surgery or dental procedure within 30 days after drug administration.
    26) Within 30 days prior to the drug administration, use of:
    • antidepressants (e.g., SSRI [citalopram, fluoxetine], SNRI
    [dexvenlafaxine, duloxetine]);
    • antiplatelet, anticoagulants or fibrinolytics (e.g., acetylsalicylic acid,
    clopidogrel, heparin, warfarin, acenocoumarol, dabigatran,
    rivaroxaban, apixaban);
    • chronic nonsteroidal anti-inflammatory drugs (NSAIDs);
    • CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole,
    clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir,
    boceprevir, telaprevir, telithromycin, conivaptan) and
    inducers (e.g., rifampin, carbamazepine, St. John's Wort, phenytoin);
    • drugs known to alter gastrointestinal pH/movement (e.g.,
    omeprazole, ranitidine).
    27) History of significant multiple and/or severe allergies (including
    latex allergy), or has had an anaphylactic reaction or significant
    intolerability to prescription or non-prescription drugs or food.
    7) History of any surgery on the oral cavity or throat in the past year.
    8) Presence of hepatic or renal dysfunction.
    E.5 End points
    E.5.1Primary end point(s)
    AUC0-last: The area under the analyte concentration versus time
    curve, from time zero (0) to the time of the last measurable analyte
    concentration, as calculated by the lin-up/log-down variant of the
    trapezoidal method.
    Cmax: Maximum measured analyte concentration over the sampling
    period.
    Tmax: Time of the maximum measured analyte concentration over the
    sampling period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (0-hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48 and 72 hours post-dose
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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) 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
    Comparative Bioavailability
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Zontivity™ 2.08 mg tabletc
    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
    Canada
    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 study specific procedure in the last period of the study or the last
    study specific procedure prior to the discontinuation of a subject from
    the study.
    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: 24
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 24
    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
    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 Pharma Medica Research Inc.
    G.4.3.4Network Country Canada
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Canada
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