<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/NCT01725230</url>
  </required_header>
  <id_info>
    <org_study_id>D4300C00039</org_study_id>
    <nct_id>NCT01725230</nct_id>
  </id_info>
  <brief_title>Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib</brief_title>
  <acronym>Statin DDI</acronym>
  <official_title>An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered&#xD;
      alone or in combination with Fostamatinib.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the&#xD;
      Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects when Administered Alone&#xD;
      and in Combination with Fostamatinib 100 mg Twice Daily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of Rosuvastatin measured by AUC and Cmax.</measure>
    <time_frame>Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of Simvastatin measured by AUC and Cmax</measure>
    <time_frame>Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of R406 measured by AUC(0-t), Cmax, Tmax (alone and in combination with rosuvastatin or simvastatin)</measure>
    <time_frame>Day 1 to day 4 at predose, Day 5 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours postdose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of rosuvastatin measured by AUC(0-t), t1/2, Tmax, Cl/F and Vz/F (alone and in combination with fostamatinib)</measure>
    <time_frame>Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of Simvastatin measured by AUC(0-t)m t1/2, and Tmax (alone and in combination with fostamatinib)</measure>
    <time_frame>Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of simvastatin measured by AUC, Cmax, AUC(0-t), t1/2, Tmax, C1/F and Vz/F (alone and in combination with fostamatinib)</measure>
    <time_frame>Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>Measured throughout the study and 3-5 days after discharge from Period 2, approximately 72 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of adverse events</measure>
    <time_frame>Measured throughout the study and 3-5 days after discharge from Period 2, approximately 72 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single, oral dose of rosuvastatin 20mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of rosuvastatin 20 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single, oral dose of simvastatin 40 mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of simvastatin 40 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fostamatinib</intervention_name>
    <description>100-mg tablet</description>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_label>Simvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>20-mg tablet</description>
    <arm_group_label>Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin</intervention_name>
    <description>40-mg tablet</description>
    <arm_group_label>Simvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of signed and dated, written informed consent, prior to any study-specific&#xD;
             procedures&#xD;
&#xD;
          -  Volunteers will be males or females aged 18 to 55 years and with a weight of at least&#xD;
             50 kg and body mass index (BMI) between 18 and 30 kg/m2, inclusive.&#xD;
&#xD;
          -  Male volunteers should be willing to use barrier contraception, ie, condoms, from the&#xD;
             day of first dosing until 2 weeks after the last dosing with IP.&#xD;
&#xD;
          -  Females must have a negative pregnancy test at screening and on admission to the unit,&#xD;
             must not be lactating, and must be of non childbearing potential, confirmed at&#xD;
             screening .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any clinically significant disease or disorder which, in the opinion of the&#xD;
             Investigator, may either put the volunteer at risk because of participation in the&#xD;
             study, or influence the results or the volunteer's ability to participate in the&#xD;
             study.&#xD;
&#xD;
          -  History or presence of GI, hepatic, or renal disease or any other condition known to&#xD;
             interfere with absorption, distribution, metabolism, or excretion of drugs.&#xD;
&#xD;
          -  Any clinically significant illness, medical/surgical procedure, or trauma within 4&#xD;
             weeks of the first administration of IP as judged by the Investigator.&#xD;
&#xD;
          -  Any clinically significant abnormalities in clinical chemistry, hematology, or&#xD;
             urinalysis results as judged by the Investigator.&#xD;
&#xD;
          -  Any clinically significant abnormal findings in vital signs as judged by the&#xD;
             Investigator&#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>David Mathews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher D O'Brien, MD PHD</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>February 1, 2013</last_update_submitted>
  <last_update_submitted_qc>February 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fostamatinib,</keyword>
  <keyword>simvastatin,</keyword>
  <keyword>rosuvastatin,</keyword>
  <keyword>Phase I,</keyword>
  <keyword>Healthy Subjects,</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Simvastatin</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/NCT01725230
org study id: D4300C00039
nct id: NCT01725230
lead sponsor: 
A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered
      alone or in combination with Fostamatinib.
An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the
      Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects when Administered Alone
      and in Combination with Fostamatinib 100 mg Twice Daily.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics of Rosuvastatin measured by AUC and Cmax.
time frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.
measure: Pharmacokinetics of Simvastatin measured by AUC and Cmax
time frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.
measure: Pharmacokinetics of R406 measured by AUC(0-t), Cmax, Tmax (alone and in combination with rosuvastatin or simvastatin)
time frame: Day 1 to day 4 at predose, Day 5 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours postdose.
measure: Pharmacokinetics of rosuvastatin measured by AUC(0-t), t1/2, Tmax, Cl/F and Vz/F (alone and in combination with fostamatinib)
time frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.
measure: Pharmacokinetics of Simvastatin measured by AUC(0-t)m t1/2, and Tmax (alone and in combination with fostamatinib)
time frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.
measure: Pharmacokinetics of simvastatin measured by AUC, Cmax, AUC(0-t), t1/2, Tmax, C1/F and Vz/F (alone and in combination with fostamatinib)
time frame: Day 1 and Day 6 at predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours postdose.
measure: Frequency of adverse events
time frame: Measured throughout the study and 3-5 days after discharge from Period 2, approximately 72 days
measure: Severity of adverse events
time frame: Measured throughout the study and 3-5 days after discharge from Period 2, approximately 72 days
arm group label: Rosuvastatin
arm group type: Experimental
description: Single, oral dose of rosuvastatin 20mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of rosuvastatin 20 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily
arm group label: Simvastatin
arm group type: Experimental
description: Single, oral dose of simvastatin 40 mg in first period and in second period (after wash out) fostamatinib 100 mg twice daily, then single oral dose of simvastatin 40 mg plus continued oral dosing of fostamatinib 100 mg twice daily, then continue fostamatinib 100 mg twice daily
intervention type: Drug
intervention name: Fostamatinib
description: 100-mg tablet
arm group label: Rosuvastatin
arm group label: Simvastatin
intervention type: Drug
intervention name: Rosuvastatin
description: 20-mg tablet
arm group label: Rosuvastatin
intervention type: Drug
intervention name: Simvastatin
description: 40-mg tablet
arm group label: Simvastatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Mathews, MD
role: Principal Investigator
affiliation: Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211
last name: Christopher D O'Brien, MD PHD
role: Study Director
affiliation: AstraZeneca
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Rosuvastatin Calcium
mesh term: Simvastatin