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    Summary
    EudraCT Number:2011-005929-49
    Sponsor's Protocol Code Number:VX11-787-101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-23
    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
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005929-49
    A.3Full title of the trial
    A Phase 2a, Randomized, Double Blind, Placebo Controlled Study to Investigate the Effects of VX 787 Administered to Adult Volunteers Experimentally Inoculated with Live Influenza Virus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the effects of VX-787 with placebo against influenza
    A.4.1Sponsor's protocol code numberVX11-787-101
    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 SponsorVertex Pharmaceuticals Incorporated
    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 supportVertex Pharmaceuticals Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointMedical Information Center
    B.5.3 Address:
    B.5.3.1Street Address130 Waverly Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16176348789
    B.5.5Fax numbernot applicable
    B.5.6E-mailmedicalinfo@vrtx.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 nameVX-787
    D.3.2Product code VX-787
    D.3.4Pharmaceutical form Capsule
    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 codeVX-787
    D.3.9.3Other descriptive nameVX-787
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    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
    Influenza A
    E.1.1.1Medical condition in easily understood language
    Flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus 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
    The primary objective of the study is to determine the effect of oral administration of VX 787 administered post-inoculation on the AUC of viral titers quantified by nasal swab cell culture in a human challenge model of influenza.
    E.2.2Secondary objectives of the trial
    - Safety and tolerability of VX 787 in healthy adult subjects inoculated with live influenza virus
    - Safety of the GMP manufactured influenza virus inoculum strain in susceptible, healthy subjects receiving either VX 787 or placebo
    - Influenza viral kinetics from nasal swabs by RT PCR
    - Change and severity of clinical symptoms
    - Changes in the sequence of the relevant target region of influenza in nasal swabs
    - Pharmacokinetics of VX 787
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy male and female subjects
    - Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) antibody screen
    - Negative Class A drugs and alcohol screen before dosing
    - Serosuitable for the challenge strain of influenza A
    - Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the last 12 months before screening
    - Willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, contraceptive guidelines, and other study procedures, including willingness to enter and remain in quarantine (in isolation for approximately 10 days) until free of influenza infection, as determined by rapid antigen test or clinical evaluation
    E.4Principal exclusion criteria
    - Subjects who are male and their female partner (if of childbearing potential) does not agree to use medically approved methods of contraception
    - Subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period
    - Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
    - Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
    - Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge)
    - Subjects with a history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, chronic obstructive pulmonary disease, or any use of a bronchodilator or other asthma medication during adulthood
    -Regular daily smokers during the 6 months before study entry or those who have a significant history of any tobacco use at any time
    - History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia
    - Use of any prescription drugs, herbal supplements, within 4 weeks before drug IMP administration, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks before viral challenge.
    - Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation
    - Previous exposure to the IMP or similar substance(s).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is Viral AUC as calculated in cell culture of nasal swabs (quantitation of nasal swabs for viral infectivity by cell culture), from initiation of VX 787 treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days
    E.5.2Secondary end point(s)
    - Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs
    - Viral kinetics in relation to:
    o Viral AUC calculated by cell culture and/or RT-PCR
    o Duration of viral shedding by cell culture and/or RT-PCR
    o Peak viral shedding titre by cell culture and/or RT-PCR
    o Time to resolution from peak viral shedding by cell culture and/or RT-PCR
    - Clinical symptom scores
    o Composite symptom score AUC
    o Time to peak of composite symptom score, duration, and time to resolution of composite score from peak
    o Peak severity symptoms after influenza viral inoculation
    o Duration of influenza-like illness after influenza viral inoculation
    - Total tissue count and total mucus weight post challenge
    - Sequence analysis of the relevant target region of influenza
    - Pharmacokinetic parameters of VX 787 (AUC, Cmax, Cmin, tmax)


    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 28 Days
    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 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) 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 No
    E.8.1.6Cross over No
    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 trial6
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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: 140
    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 state140
    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)
    Subjects will not be offered continued treatment or medical management after the end of the trial. Vertex will inform subjects of this in writing. Any subject who does not give their written consent to this conidition will not be allowed to participate in the study.
    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 Decision2012-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-05
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