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    Summary
    EudraCT Number:2012-002413-19
    Sponsor's Protocol Code Number:GS-US-218-0103
    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:2012-09-07
    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 number2012-002413-19
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Volunteers Infected with Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate GS-5806 in Volunteers Infected with Respiratory Syncytial Virus
    A.4.1Sponsor's protocol code numberGS-US-218-0103
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Limited
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1223 897496
    B.5.5Fax number+44 1223 897284
    B.5.6E-mailclinical.trials@gilead.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.3.2Product code GS-5806
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNGS-5806
    D.3.9.1CAS number 1353625-73-6
    D.3.9.2Current sponsor codeGS-5806
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300.0
    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 placeboPowder for oral solution
    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
    Respiratory Syncytial Virus (RSV) Infection
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus (RSV) Infection is a respiratory virus that infects the lungs and breathing passages.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10039247
    E.1.2Term RSV 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 evaluate the antiviral effect of GS-5806 in healthy adults infected with RSV-A Memphis 37b (RSV).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effect of GS-5806 on various viral load-related and symptom-related endpoints, to evaluate the safety and tolerability of GS 5806, and to evaluate the pharmacokinetic (PK) profile of GS-5806 among subjects who have been inoculated with RSV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy males and females
    2. Age 18 to 45 years inclusive
    3. Body mass index of 18 to 33 kg/m2 inclusive; total body weight ≥ 50 kg.
    4. Agreement to use acceptable contraceptive methods if they are heterosexually active
    5. An informed consent document signed and dated by the subject and Investigator
    6. Sero-suitable for challenge strain of RSV
    E.4Principal exclusion criteria
    1. Presence of any significant acute or chronic, uncontrolled medical illness, that in the view of the Investigator(s), is associated with increased risk of complications of respiratory viral illness
    2. Any history during adulthood of asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology
    3. History or evidence of autoimmune disease or known impaired immune responsiveness (of any cause)
    4. Confirmed positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) test
    5. Recent (within the last 3 years of the screening visit) and/or recurrent history of clinically significant autonomic dysfunction (eg, recurrent episodes of fainting, palpitations, etc.)
    6. Any significant abnormality altering the anatomy of the nose or nasopharynx
    7. Any clinically significant history of epistaxis
    8. Any nasal or sinus surgery within 6 months of inoculation
    9. Significant history of any tobacco use at any time (≥ total 10 pack year history [eg, 1 pack a day for 10 years])
    10. Venous access inadequate for phlebotomy demands of the study
    11. Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities in spirometry
    12. Receipt of any investigational drug within 3 months prior to inoculation, or prior participation in a clinical trial of any RSV IMP, prior participation in a clinical trial using RSV or any other respiratory human viral challenge within 1 year prior to inoculation, or receipt of more than 4 investigational drugs within the previous 12 months
    13. Known allergy to components of the Challenge Virus inoculum
    14. Symptoms of hay fever on admission into the Quarantine Unit or prior to inoculation
    15. Intending to travel within the next 3 months to countries for which vaccinations are recommended
    16. Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within 2 weeks of human viral challenge. Healthcare workers should not work with patients until 14 days after challenge or until their symptoms are fully resolved (whichever is the longer). In particular, any health care workers who work in units housing, elderly, disabled or severely immuno-compromised patients (eg, bone marrow transplant units) will be excluded from participating in the study
    17. Those employed or immediate relatives of those employed at RVL or Gilead Sciences
    18. Confirmed positive drug screen for class A drugs of abuse or alcohol that cannot be satisfactorily explained (eg, recent use of codeine tablets)
    19. Presence of a household member or close contact with someone (for an additional 2 weeks after discharge from the isolation facility) who:
    • is less than 3 years of age
    • has any known immunodeficiency
    • is receiving immunosuppressant medications
    • is undergoing or soon to undergo cancer chemotherapy within 28 days of viral inoculation
    • has diagnosed emphysema or COPD, is elderly residing in a nursing home, or has severe lung disease or medical condition that may the conditions listed (not exhaustively) in Appendix 2; or
    • has received a transplant (bone marrow or solid organ)
    20. Any laboratory test or electrocardiogram (ECG) which is abnormal and deemed by the Investigator(s) to be clinically significant
    21. Pregnant or nursing, or has a positive pregnancy test at any point in the study, or male subjects whose partners are pregnant
    22. Presence of any significant respiratory symptoms existing on the day of inoculation or between admission for quarantine and viral inoculation. History suggestive of respiratory infection within 14 days prior to admission into the Quarantine Unit
    23. Acute use (ie, within 7 days prior to human viral challenge) of any medication or other product (prescription or over-the-counter [OTC]), for symptoms of hay fever, rhinitis, nasal congestion, or respiratory tract infection
    24. Receipt of systemic glucocorticoids, antiviral drugs, and immunoglobulins (Igs), or any other cytotoxic or immunosuppressive drug within 6 months prior to dosing. Receipt of any systemic chemotherapy agent at any time
    25. Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the 3 months prior to inoculation
    26. Any other finding in the medical interview, physical exam, or screening investigations that, in the opinion of the Investigator, General Practitioner (GP) or Sponsor deem the subject unsuitable for the study
    27. Known allergy to components of the IMP (anhydrous citric acid or mannitol) or apple juice
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the area under the curve (AUC) viral load as measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) assay from the first viral load measurement post initial dose of investigational medicinal product (IMP) through Day 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post initial dose of IMP, twice daily (AM and PM), through Day 12
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    • AUC of viral load post challenge through Day 12 as measured by the qRT-PCR assay
    • Total weight of mucus produced post initial dose of IMP through last administration of IMP
    • AUC of change from baseline of symptoms post initial dose of IMP
    Other Endpoints of Interest.
    • AUC of viral load from the first viral load measurement post initial dose of IMP through last administration
    • Duration of viral shedding from initial dose of IMP to last positive viral load detection (through Day 12)
    • Delta peak viral load, as measured by the difference between the viral load on day of peak (for each subject) and the viral load on the 1st detection of viral shedding (for that subject)
    • Absolute peak viral load
    • Time to peak viral load, as measured from initial dose of IMP
    • Time to resolution of viral shedding, as measured from day of peak viral load to last positive virus detection through Day 12
    • Total weight of mucus produced post initial dose of IMP through Day 12
    • AUC of symptoms after challenge
    • AUC of symptoms after challenge until last administration of IMP
    • Peak symptoms after challenge
    • Peak symptoms post viral inoculation up to last dose of IMP
    Viral load endpoints will be analyzed by both qRT-PCR and plaque assay measurement methods. Duration of viral shedding will be analyzed by qRT-PCR and plaque assay.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol.
    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 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 Yes
    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 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.

    Due to the design of the study, (viral challenge study), it may be necessary from a medical safety perspective to follow up any subject beyond the last scheduled visit as a duty of care and in line with International Conference on Harmonisation-E6 (ICH-E6). However, these discretionary follow up visits will not be considered part of the study data (unless this represents follow up and closure on an AE or SAE identified during the study period).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 100
    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 state100
    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)
    See protocol.
    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 Decision2012-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-27
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