<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/NCT02262715</url>
  </required_header>
  <id_info>
    <org_study_id>CR105145</org_study_id>
    <secondary_id>VX-787FLZ1001</secondary_id>
    <secondary_id>2014-002528-28</secondary_id>
    <nct_id>NCT02262715</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Drug-Drug Interaction Between VX-787 and Oseltamivir</brief_title>
  <official_title>A Phase 1, Randomized, 3-way Crossover, Open-label Study to Assess the Drug-drug Interaction Between VX-787 and Tamiflu®, Followed by a Double-blind, Randomized, Placebo-controlled Study to Collect Safety, Tolerability and Pharmacokinetics of VX-787, in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Infectious Diseases BVBA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Infectious Diseases BVBA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the drug-drug interaction between VX-787 and&#xD;
      oseltamivir, when co-administered at steady-state in healthy participants. In addition the&#xD;
      safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the&#xD;
      blood and tissues over time) of VX-787 will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of 2 parts. Part 1 is an open-label (a medical research study in which&#xD;
      participants and researchers are told which treatments the participants are receiving),&#xD;
      randomized (treatment group assigned by chance), 3-way crossover (a method used to switch&#xD;
      participants from one treatment group to another in a clinical trial) study to estimate&#xD;
      drug-drug interaction between VX-787 and oseltamivir. It consists of 3 phases: a Screening&#xD;
      phase, a Treatment phase and a Follow-up phase. Treatment phase will include 3 treatment&#xD;
      sessions, each of the participant will receive Treatment A (VX-787, 600 milligram [mg] 2&#xD;
      times a day on Day 1 to 4, followed by a single dose of VX 787, 600 mg on Day 5); Treatment B&#xD;
      (Oseltamivir, 75 mg 2 times a day on Day 1 to 4, followed by a single dose of oseltamivir 75&#xD;
      mg on Day 5) and Treatment C (VX-787, 600 mg 2 times a day + oseltamivir, 75 mg 2 times a day&#xD;
      on Day 1 to 4, followed by a single dose of VX-787, 600 mg + a single dose of oseltamivir, 75&#xD;
      mg on Day 5). Each treatment session will be separated by a wash-out period of 5 days. The&#xD;
      order each participant will receive treatments A, B and C will be decided at randomization.&#xD;
&#xD;
      Part 2 is double-blind (a medical research study in which neither the researchers nor the&#xD;
      participants know what treatment the subjects is receiving), randomized, placebo-controlled.&#xD;
      It consists of 3 phases: a Screening phase, a Treatment phase and a Follow-up phase. In&#xD;
      Treatment phase participants will be randomly assigned VX-787, 600 mg or placebo 2 times a&#xD;
      day, on Day 1 to 9, followed by a single dose of VX-787 600 mg or placebo in the morning on&#xD;
      Day 10. Pharmacokinetic parameters will be assessed primarily. Participants' safety will be&#xD;
      monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the drug-drug interaction between VX-787 600 mg bid coadministered with oseltamivir 75 mg bid at steady-state in healthy participants</measure>
    <time_frame>Day 5</time_frame>
    <description>Based on the individual plasma concentration-time data, using the actual sampling times the following PK parameters will be derived: Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/refrence (ref), Ratio Cmin,test/ref and ratio AUC12h, test/ref</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the safety and tolerability of a VX-787 600 mg bid regimen during 10 days in healthy participants</measure>
    <time_frame>Days 1-10</time_frame>
    <description>Safety and tolerability will be evaluated throughout the study from signing of the ICF onwards until the last study-related activity. The study will include the following evaluations of safety and tolerability: Adverse Events, Clinical Laboratory Test, Electrocardiograms, Vital Signs, Physical Exams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Pharmacokinetics of VX-787</measure>
    <time_frame>Days 1-10</time_frame>
    <description>Pharmacokinetic parameters will include assessment of Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/ref, ratio Cmin,test/ref and ratio AUC12h,test/ref.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigate the short-term safety and tolerability of the concomitant use of VX-787 and oseltamivir in healthy participants</measure>
    <time_frame>Days 1-5</time_frame>
    <description>Safety and tolerability will be evaluated throughout the study from signing of the ICF onwards until the last study-related activity. The study will include the following evaluations of safety and tolerability: Adverse Events, Clinical Laboratory Test, Electrocardiograms, Vital Signs, Physical Exams</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive in random order Treatment A (VX-787, 600 mg tablet 2 times a day on Day 1 to 4, followed by VX 787, 600 mg tablet on Day 5); Treatment B (Oseltamivir, 75 mg capsule 2 times a day on Day 1 to 4, followed by oseltamivir 75 mg capsule in the morning on Day 5) or Treatment C (VX-787, 600 mg tablet, 2 times a day orally + oseltamivir, 75 mg capsule, 2 times a day on Day 1 to 4, followed by a single dose of VX-787, 600 mg + oseltamivir, 75 mg capsule on Day 5). Each participant will receive all three treatments (Treatment A, B and C) in a random sequence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 VX-787</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive VX-787, 600 mg, tablet 2 times a day, orally on Day 1 to Day 9, followed by single dose of VX-787, 600 mg on Day 10.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive placebo matching to VX-787, 2 times a day, orally on Day 1 to Day 9, followed by single dose of matching placebo on Day 10.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-787</intervention_name>
    <description>Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part.</description>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_label>Part 2 VX-787</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oseltamivir</intervention_name>
    <description>Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part.</description>
    <arm_group_label>Part 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo matching to VX-787 either two times a day or or once a day.</description>
    <arm_group_label>Part 2 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female participants must be of non-childbearing potential: postmenopausal for at least&#xD;
             2 years (amenorrheal for at least 3 years and a serum follicle stimulating hormone&#xD;
             [FSH] level greater than [&gt;] 40 international unit per liter [IU/L]), or surgically&#xD;
             sterile (have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal&#xD;
             ligation/bilateral tubal clips without reversal operation), or otherwise incapable of&#xD;
             becoming pregnant&#xD;
&#xD;
          -  Participants must be non-smoking or smoking no more than 10 cigarettes, or 2 cigars,&#xD;
             or 2 pipes per day for at least 3 months prior to screening&#xD;
&#xD;
          -  Participants must have a Body Mass Index (BMI: weight in kg divided by the square of&#xD;
             height in meters) of 18.0 to 30.0 kilogram per meter square [kg/m^2]&#xD;
&#xD;
          -  Participants must be willing/able to adhere to the prohibitions and restrictions&#xD;
             specified in the protocol and study procedures&#xD;
&#xD;
          -  Participants must be healthy on the basis of a medical evaluation that reveals the&#xD;
             absence of any clinically significant abnormality and includes a physical examination,&#xD;
             medical history, vital signs and the results of blood biochemistry, blood coagulation&#xD;
             and hematology test and a urinalysis performed at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with a past history of heart arrhythmias (for example, extrasystoli,&#xD;
             tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for&#xD;
             example, hypokalemia, family history of long QT Syndrome)&#xD;
&#xD;
          -  Participants with a history or evidence of use of alcohol, barbiturates, amphetamines,&#xD;
             recreational or narcotic drug use within the past 1 year, which in the Investigator's&#xD;
             opinion would compromise participant's safety and/or compliance with the study&#xD;
             procedures&#xD;
&#xD;
          -  Participants with current hepatitis A infection (confirmed by hepatitis A antibody&#xD;
             immunoglobulin M [IgM]), or hepatitis B infection (confirmed by hepatitis B surface&#xD;
             antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV]&#xD;
             antibody), or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study&#xD;
             screening&#xD;
&#xD;
          -  Participants having a positive urine drug test or alcohol breath test at study&#xD;
             screening. Urine will be tested for the presence of amphetamines, benzodiazepines,&#xD;
             cocaine, cannabinoids, opioids, methadone and barbiturates&#xD;
&#xD;
          -  Participants with known allergies, hypersensitivity, or intolerance to VX-787,&#xD;
             oseltamivir, or excipients of the drug products used&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Infectious Diseases BVBA Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Infectious Diseases BVBA</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Merksem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>November 3, 2014</last_update_submitted>
  <last_update_submitted_qc>November 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oseltamivir</keyword>
  <keyword>VX-787</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oseltamivir</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02262715
org study id: CR105145
secondary id: VX-787FLZ1001
secondary id: 2014-002528-28
nct id: NCT02262715
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the drug-drug interaction between VX-787 and
      oseltamivir, when co-administered at steady-state in healthy participants. In addition the
      safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the
      blood and tissues over time) of VX-787 will be assessed.
This study consists of 2 parts. Part 1 is an open-label (a medical research study in which
      participants and researchers are told which treatments the participants are receiving),
      randomized (treatment group assigned by chance), 3-way crossover (a method used to switch
      participants from one treatment group to another in a clinical trial) study to estimate
      drug-drug interaction between VX-787 and oseltamivir. It consists of 3 phases: a Screening
      phase, a Treatment phase and a Follow-up phase. Treatment phase will include 3 treatment
      sessions, each of the participant will receive Treatment A (VX-787, 600 milligram [mg] 2
      times a day on Day 1 to 4, followed by a single dose of VX 787, 600 mg on Day 5); Treatment B
      (Oseltamivir, 75 mg 2 times a day on Day 1 to 4, followed by a single dose of oseltamivir 75
      mg on Day 5) and Treatment C (VX-787, 600 mg 2 times a day + oseltamivir, 75 mg 2 times a day
      on Day 1 to 4, followed by a single dose of VX-787, 600 mg + a single dose of oseltamivir, 75
      mg on Day 5). Each treatment session will be separated by a wash-out period of 5 days. The
      order each participant will receive treatments A, B and C will be decided at randomization.

      Part 2 is double-blind (a medical research study in which neither the researchers nor the
      participants know what treatment the subjects is receiving), randomized, placebo-controlled.
      It consists of 3 phases: a Screening phase, a Treatment phase and a Follow-up phase. In
      Treatment phase participants will be randomly assigned VX-787, 600 mg or placebo 2 times a
      day, on Day 1 to 9, followed by a single dose of VX-787 600 mg or placebo in the morning on
      Day 10. Pharmacokinetic parameters will be assessed primarily. Participants' safety will be
      monitored throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Assess the drug-drug interaction between VX-787 600 mg bid coadministered with oseltamivir 75 mg bid at steady-state in healthy participants
time frame: Day 5
description: Based on the individual plasma concentration-time data, using the actual sampling times the following PK parameters will be derived: Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/refrence (ref), Ratio Cmin,test/ref and ratio AUC12h, test/ref
measure: Evaluate the safety and tolerability of a VX-787 600 mg bid regimen during 10 days in healthy participants
time frame: Days 1-10
description: Safety and tolerability will be evaluated throughout the study from signing of the ICF onwards until the last study-related activity. The study will include the following evaluations of safety and tolerability: Adverse Events, Clinical Laboratory Test, Electrocardiograms, Vital Signs, Physical Exams.
measure: Assessment of Pharmacokinetics of VX-787
time frame: Days 1-10
description: Pharmacokinetic parameters will include assessment of Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/ref, ratio Cmin,test/ref and ratio AUC12h,test/ref.
measure: Investigate the short-term safety and tolerability of the concomitant use of VX-787 and oseltamivir in healthy participants
time frame: Days 1-5
description: Safety and tolerability will be evaluated throughout the study from signing of the ICF onwards until the last study-related activity. The study will include the following evaluations of safety and tolerability: Adverse Events, Clinical Laboratory Test, Electrocardiograms, Vital Signs, Physical Exams
arm group label: Part 1
arm group type: Experimental
description: Participants will receive in random order Treatment A (VX-787, 600 mg tablet 2 times a day on Day 1 to 4, followed by VX 787, 600 mg tablet on Day 5); Treatment B (Oseltamivir, 75 mg capsule 2 times a day on Day 1 to 4, followed by oseltamivir 75 mg capsule in the morning on Day 5) or Treatment C (VX-787, 600 mg tablet, 2 times a day orally + oseltamivir, 75 mg capsule, 2 times a day on Day 1 to 4, followed by a single dose of VX-787, 600 mg + oseltamivir, 75 mg capsule on Day 5). Each participant will receive all three treatments (Treatment A, B and C) in a random sequence.
arm group label: Part 2 VX-787
arm group type: Experimental
description: Participants will receive VX-787, 600 mg, tablet 2 times a day, orally on Day 1 to Day 9, followed by single dose of VX-787, 600 mg on Day 10.
arm group label: Part 2 Placebo
arm group type: Experimental
description: Participants will receive placebo matching to VX-787, 2 times a day, orally on Day 1 to Day 9, followed by single dose of matching placebo on Day 10.
intervention type: Drug
intervention name: VX-787
description: Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part.
arm group label: Part 1
arm group label: Part 2 VX-787
intervention type: Drug
intervention name: Oseltamivir
description: Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part.
arm group label: Part 1
intervention type: Other
intervention name: Placebo
description: Participants will receive placebo matching to VX-787 either two times a day or or once a day.
arm group label: Part 2 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Infectious Diseases BVBA Clinical Trial
role: Study Director
affiliation: Janssen Infectious Diseases BVBA
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Oseltamivir