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    Summary
    EudraCT Number:2011-004804-38
    Sponsor's Protocol Code Number:073-202
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-17
    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
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-004804-38
    A.3Full title of the trial
    A Randomized, Blinded, Placebo-Controlled, Poliovirus Challenge Study To Evaluate The Therapeutic Efficacy, Safety, Tolerability And Pharmacokinetics Of Orally Administered V-073 In Healthy Adult Volunteers Receiving Type 1 Monovalent Oral Poliovirus Vaccine (mOPV1).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Blinded, Placebo-Controlled, Poliovirus Challenge Study To Evaluate The Therapeutic Efficacy, Safety, Tolerability And Pharmacokinetics Of Orally Administered V-073 In Healthy Adult Volunteers Receiving Type 1 Monovalent Oral Poliovirus Vaccine (mOPV1).
    A.4.1Sponsor's protocol code number073-202
    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 SponsorViroDefense 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 supportViroDefense Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViroDefense Inc
    B.5.2Functional name of contact pointDr Marc S. Collett
    B.5.3 Address:
    B.5.3.1Street Address155 Gibbs Street, Suite 529
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850-0395
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 301 340 1135
    B.5.5Fax number+1 202 966 7545
    B.5.6E-mailMscollett@aol.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 nameV-073 200 mg
    D.3.2Product code V-073
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeV-073
    D.3.9.3Other descriptive nameV-073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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, hard
    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
    Poliomyelitis
    E.1.1.1Medical condition in easily understood language
    Polio
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10036017
    E.1.2Term Poliomyelitis viral infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    · To determine the effect of V-073 and placebo treatment on poliovirus serotype 1 excretion in the stool after administration of mOPV1 as determined by virus culture;
    · To evaluate the safety and tolerability of multiple oral doses of V-073 administered to healthy volunteers;
    E.2.2Secondary objectives of the trial
    · To evaluate the pharmacokinetics profile of V-073 after administration of multiple oral doses;
    · To determine the duration of poliovirus excretion in V-073 and placebo treated subjects;
    · To determine the levels of poliovirus excretion over time with V-073 or placebo treatment;
    · To compare the effectiveness of V-073 on poliovirus excretion when administered afterconsumption of a standard and high fat meal;
    · To determine the initial and post-V-073 treatment susceptibility of excreted poliovirus to V-073;
    · To determine the poliovirus-specific serum IgA and serum neutralizing (SN) antibody levels before and after treatment with V-073.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a healthy, non-smoking male or female of any race, having received prior vaccination with inactivated polio vaccine, and at
    least 18 years old and no more than 50 years old, inclusively;
    2. Have a body mass index (BMI) within the range of >18.5 and <30 unless
    approved by the Sponsor and Investigator;
    3. Be healthy as determined by pre study medical history, physical examination,
    12 lead ECG and clinical laboratory evaluations;
    4. Be positive for total serum IgA (indicative of immunocompetence);
    5. Be negative for poliovirus-specific serum IgA (serotype 1) (indicative of no prior exposure to live poliovirus);
    6. Have no history of immunodeficiency;
    7. Have regular bowel movements, at least once per day (self reported);
    8. Be informed of the nature of the study and provide written informed consent;
    9. Be legally competent and able to communicate effectively with study personnel.
    E.4Principal exclusion criteria
    1. A history of natural or OPV-derived poliovirus infection;
    2. Female subjects who are pregnant, attempting to become pregnant or lactating;
    3. Any disease or condition that might compromise the cardiovascular,
    hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine
    (e.g., diabetes), central nervous, or gastrointestinal (including a gastric or
    duodenal ulcer) systems;
    4. The presence of clinically significant abnormal laboratory values in the opinion
    of the Investigator or Sponsor;
    5. A history of alcoholism or drug addiction within the past 2 years, recent use of
    any recreational drugs, or positive results from a urine screen for substances of
    abuse and alcohol at screening and admission;
    6. A history of serious mental illness, that includes but is not limited to
    schizophrenia, bipolar disorder, or severe depression requiring hospitalization or
    pharmacological intervention;
    7. Is a member of a household in which another member is known to be
    immunodeficient or is actively being treated for a malignancy, autoimmune
    disease or transplant;
    8. A history of difficulty donating blood or inadequate venous access;
    9. The donation of blood or plasma within 30 days prior to receiving study drug;
    10. Lactose intolerant;
    11. A positive hepatitis screen that tests for both hepatitis B surface antigen (HBsAg)
    and antibody to hepatitis C (HCV);
    12. A positive test result for HIV antibody by enzyme immunoassay which is
    confirmed by Western immunoblot;
    13. Receipt of an investigational drug or product, or participation in a drug study
    within a period of 30 days prior to receiving study drug (for investigational drugs
    with an elimination half-life greater than 10 days, this will be extended to 60
    days);
    14. Use of any drug or medication known to suppress/inhibit the immune system
    (e.g., steroids such as prednisone);
    15. Use of a drug therapy known to induce or inhibit hepatic drug metabolism within
    30 days prior to receiving study drug or during the study.
    16. Use of any prescription or over-the-counter (OTC) drug therapy, excluding
    paracetamol and including herbal, homeopathic, vitamins, minerals and
    nutritional supplements, unapproved by the Sponsor, within 2 weeks prior to
    receiving the study drug (for drugs with an elimination half-life greater than 10
    days, this will be extended to 60 days).
    17. Use of grapefruits and grapefruit-containing juices within 1 week prior to dosing.
    18. Unable to follow the restrictions outlined in the protocol ; or judgment by the PI that the subject should not participate in the study;
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics:
    • The primary pharmacokinetic measure will be the single and multiple dose plasma pharmacokinetics of V-073

    Pharmacodynamics:
    • Stool samples will be assessed for virus both qualitatively and quantitatively in a virusinduced cytopathic effect cell culture assay.
    • Stool samples may be assessed for virus qualitatively using poliovirus specific RT-PCR methodology.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetics:
    • The primary pharmacokinetic measure will be the single and multiple dose plasma pharmacokinetics of V-073;
    • Pharmacokinetic parameters for Day 3 and Day 16 QD dosing will include Cmax, tmax, C24,AUC(0-tau),;
    • Cmin (trough) levels of V-073 will be determined by analyzing plasma samples collected prior to the morning dose on Days 4-16, and 24h after the last dose.
    Pharmacodynamics:
    The resulting virology data will be analyzed for the following endpoints
    - Time to virus excretion negativity for chloroform extracted samples.
    -Time to virus excretion negativity for non-chloroform extracted samples.
    -Daily % subjects virus excretion negative for all sample collection days.
    E.5.2Secondary end point(s)
    Drug Susceptibility Group 1 to 4, Group 7 and 8:
    Virus from each subject's virus culture positive chloroform-extracted stool sample on Day 3 (or Day 2 if Day 3 sample is not available; pretreatment) and their last virus culture positive stool sample will be assessed for susceptibility to V-073 in a cell culture virus-induced cytopathic effect assay (EC50 determination). Virus samples with reduced drug susceptibility (defined as a
    >20-fold increase in EC50 value relative to the corresponding Day 3 [pretreatment] susceptibility) will be sequenced across the VP3 and VP1 protein coding regions to determine the genetic basis for reduced drug susceptibility.

    Safety:
    Safety and tolerability will be assessed by monitoring adverse
    experiences, measuring vital signs, electrocardiograms (ECGs),
    assessment of clinical laboratory determinations from blood samples, and performance of physical examinations

    Group 5 and 6:
    Drug Susceptibility:
    Virus from each subject’s virus culture positive chloroform-extracted stool sample on Day 1 (or Day 0 if Day 1 sample is not available; pretreatment) and their last virus culture positive stool sample will be assessed for susceptibility to V-073 in a cell culture virus-induced cytopathic effect assay (EC50 determination). Virus samples with reduced drug susceptibility (defined as a
    >20-fold increase in EC50 value relative to the corresponding Day 1 [pretreatment] susceptibility) will be sequenced across the VP3 and VP1 protein coding regions to determine the genetic basis for reduced drug susceptibility.

    Safety:
    Safety and tolerability will be assessed by monitoring adverse experiences, measuring vital signs, electrocardiograms (ECGs), assessment of clinical laboratory determinations from blood samples, and performance of physical examinations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Drug Susceptibility:
    Group 1 to 4, Group 7 and 8
    Day 3 (or Day 2 if Day 3 sample is not available; pretreatment) and their
    last virus culture positive stool
    Safety:
    Day 0 to Day 45

    Group 5 and 6:
    Drug Susceptibility:
    Day 1 (or Day 0 if Day 1 sample is not available; pretreatment) and their last virus culture positive stool

    Safety:
    Day 0 to Day 43
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Virus challenge study
    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
    LVLS
    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 months10
    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: 144
    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 state144
    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)
    N/A
    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 Decision2011-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-19
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