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    Summary
    EudraCT Number:2016-004728-48
    Sponsor's Protocol Code Number:MK-1439-043
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-11-23
    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 number2016-004728-48
    A.3Full title of the trial
    A Study to Evaluate the Comparative Bioavailability of the Investigational Oral Pediatric Minitablet Formulation of MK-1439 Compared to the Adult Formulation of MK-1439 in Healthy Adult Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pediatric Formulation Study
    A.3.2Name or abbreviated title of the trial where available
    Pediatric Formulation Study
    A.4.1Sponsor's protocol code numberMK-1439-043
    A.5.4Other Identifiers
    Name:NOVUM STUDY NO.Number:11502901
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/139/2016
    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, a subsidiary of Merck & Co., Inc.
    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, a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointMartin Otto Behm
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive - P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station
    B.5.3.3Post codeNJ 08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267-305-7110
    B.5.6E-mailmartin.behm@merck.com
    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 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 nameDoravirine
    D.3.2Product code MK-1439
    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 INNDoravirine
    D.3.9.2Current sponsor codeMK-1439
    D.3.9.3Other descriptive nameMK-1439
    D.3.9.4EV Substance CodeSUB107739
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameDoravirine - minitablets -100 mg total dose
    D.3.2Product code MK-1439
    D.3.4Pharmaceutical form Tablet
    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 INNDoravirine
    D.3.9.2Current sponsor codeMK-1439
    D.3.9.3Other descriptive nameMK-1439
    D.3.9.4EV Substance CodeSUB107739
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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
    HIV – Human Immunodeficiency Virus
    E.1.1.1Medical condition in easily understood language
    HIV – Human Immunodeficiency Virus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV 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
    To evaluate the comparative bioavailability of a single-dose of the investigational oral pediatric minitablet formulation of MK-1439, 0.8 mg [100 mg total dose] compared to the adult formulation of MK-1439 tablets, 100 mg in healthy adult male and female subjects under fasted conditions.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Non-tobacco using males and non-pregnant females, 18-55 years of age, inclusive.
    2. A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
    3. Alkaline phosphatase, alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), and bilirubin (total and direct) are below the upper limit of normal based on the clinically acceptable normal range; obtained from the clinical laboratory tests performed at screening.
    4. If female and of childbearing potential, prepared to abstain from sexual intercourse, or have used and agree to continue to use a reliable method of contraception (e.g., hormonal contraceptives, condom with spermicide, IUD) for at least 30 days before initial dosing and throughout the duration of the study.
    5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
    6. Able to consume the entire contents of a 6 oz. container of lowfat vanilla or french vanilla yogurt (e.g., Stonyfield Organic™ Smooth & Creamy lowfat french vanilla yogurt) within 10 minutes, at screening.
    7. Signed and dated written informed consent form for the trial, which meets all criteria of current ICH, FDA and state regulations.
    E.4Principal exclusion criteria
    1. Females who are pregnant, lactating or likely to become pregnant during the study.
    2. History of allergy or sensitivity to MK-1439 or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of study.
    3. Lactose intolerant.
    4. Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension), stroke, renal or hepatic disorder, diabetes or bleeding disorders.
    5. Clinically significant history or presence of gastrointestinal disease or malabsorption within the last year, as determined by the Investigator.
    6. Presence of a medical condition requiring regular treatment with prescription drugs (except hormonal contraceptives).
    7. History of psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.
    8. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes (e.g., CYP3A4) within 30 days before initial dosing.
    9. Receipt of any drug as part of a research study within 30 days before initial dosing.
    10. Drug or alcohol addiction requiring treatment in the past 12 months.
    11. History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
    12. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.
    13. Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
    14. Positive test results for drugs of abuse at screening.
    15. If female, has a positive serum pregnancy test at screening.
    16. Use of tobacco products, or other nicotine containing products such as patches or gum within 90 days before initial dosing.
    17. Difficulty fasting, eating yogurt, or eating the standard meals that will be provided during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The following PK parameters will be estimated for MK-1439:

    AUC0-last: The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down trapezoidal method

    AUC0-inf: The area under the analyte concentration versus time curve from time zero to infinity. AUC0-inf = AUC0-last + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration

    C24hr: The concentration of the analyte in plasma at 24 hours post administration

    Cmax: Maximum measured analyte concentration over the sampling period

    Tmax: Time of the maximum measured analyte concentration over the sampling period

    Kel: The apparent first-order elimination rate constant

    T½: The apparent elimination half-life

    CL/F: Apparent total plasma clearance of drug after oral administration (CL/F = Dose/AUC0-inf)

    Vd/F: Apparent volume of distribution during the terminal phase after oral drug administration (Vd/F = Dose/[AUC0-inf*Kel])
    E.5.1.1Timepoint(s) of evaluation of this end point
    0, 0.5, 1, 1.5, 2, 2.5, 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
    MK-1439 Adult Formulation Tablet
    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
    United States
    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 days16
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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