<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03258502</url>
  </required_header>
  <id_info>
    <org_study_id>REVC002</org_study_id>
    <secondary_id>2017-001282-24</secondary_id>
    <nct_id>NCT03258502</nct_id>
  </id_info>
  <brief_title>A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection</brief_title>
  <official_title>A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Pharmacokinetics And Antiviral Activity Of Multiple Doses Of RV521 Against Respiratory Syncytial Virus Infection In The Virus Challenge Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to learn about the safety, pharmacokinetics and antiviral&#xD;
      activity of the study medicine (called sisunatovir/RV521) for the potential treatment of&#xD;
      respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the&#xD;
      treatment period. RSV is a highly contagious virus that can lead to serious lung infections&#xD;
      in patients with reduced ability to fight infection. Most vulnerable populations include&#xD;
      babies, the elderly and patients that have received a bone marrow transplant.&#xD;
&#xD;
      This study is seeking healthy participants who are:&#xD;
&#xD;
        1. Aged 18 to 45 years old and will agree to the use of highly effective methods of&#xD;
           contraception.&#xD;
&#xD;
        2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts&#xD;
           of 33 participants each. In both cohorts participants will be exposed to the challenge&#xD;
           virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo&#xD;
           (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5&#xD;
           days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5&#xD;
           days. Participants will start taking the study medicine upon confirmation of RSV&#xD;
           infection (or evening of Day 5 if not positive to RSV). The study medicine will be&#xD;
           administered 12 hours apart (or twice daily). Each participant will remain in the&#xD;
           quarantine unit until discharge on Day 12.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in viral load</measure>
    <time_frame>Baseline to study day 12</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Respiratory Syncytial Virus Infections</condition>
  <arm_group>
    <arm_group_label>RV521</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RV521 drug substance in capsule for oral administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Micro-crystalline cellulose in capsule for oral administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RV521</intervention_name>
    <description>RV521 drug in capsules</description>
    <arm_group_label>RV521</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo in capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 45 years, inclusive&#xD;
&#xD;
          -  In good health with no history of major medical conditions&#xD;
&#xD;
          -  A total body weight ≥ 50 kg and a body mass index (BMI) of &gt;/=18kg/m2 and &lt;/=30kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of any clinically significant or currently active major medical condition&#xD;
&#xD;
          -  Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test&#xD;
&#xD;
          -  Significant nose or nasopharynx abnormalities&#xD;
&#xD;
          -  Abnormal lung function&#xD;
&#xD;
          -  History or currently active symptoms suggestive of upper or lower respiratory tract&#xD;
             infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>hVIVO Services Ltd</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=REVC002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258502
org study id: REVC002
secondary id: 2017-001282-24
nct id: NCT03258502
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to learn about the safety, pharmacokinetics and antiviral
      activity of the study medicine (called sisunatovir/RV521) for the potential treatment of
      respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the
      treatment period. RSV is a highly contagious virus that can lead to serious lung infections
      in patients with reduced ability to fight infection. Most vulnerable populations include
      babies, the elderly and patients that have received a bone marrow transplant.

      This study is seeking healthy participants who are:

        1. Aged 18 to 45 years old and will agree to the use of highly effective methods of
           contraception.

        2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts
           of 33 participants each. In both cohorts participants will be exposed to the challenge
           virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo
           (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5
           days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5
           days. Participants will start taking the study medicine upon confirmation of RSV
           infection (or evening of Day 5 if not positive to RSV). The study medicine will be
           administered 12 hours apart (or twice daily). Each participant will remain in the
           quarantine unit until discharge on Day 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in viral load
time frame: Baseline to study day 12
arm group label: RV521
arm group type: Experimental
description: RV521 drug substance in capsule for oral administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Micro-crystalline cellulose in capsule for oral administration
intervention type: Drug
intervention name: RV521
description: RV521 drug in capsules
arm group label: RV521
intervention type: Drug
intervention name: Placebo
description: Placebo in capsules
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United Kingdom
url: https://pmiform.com/clinical-trial-info-request?StudyID=REVC002
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Respiratory Syncytial Virus Infections
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests