<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/NCT01711827</url>
  </required_header>
  <id_info>
    <org_study_id>9766-CL-0024</org_study_id>
    <nct_id>NCT01711827</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects</brief_title>
  <official_title>A Phase 1, Open-label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Basilea Pharmaceutica International Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the&#xD;
      pharmacokinetics of prednisolone after single dose administration of prednisone. This study&#xD;
      will also assess the safety and tolerability of isavuconazole alone and in combination with&#xD;
      prednisone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of plasma prednisolone: AUClast,</measure>
    <time_frame>Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose</time_frame>
    <description>Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUC last)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of plasma prednisolone: AUCinf</measure>
    <time_frame>Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose</time_frame>
    <description>AUC from the time of dosing to infinity (AUCinf),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of plasma prednisolone: Cmax</measure>
    <time_frame>Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose</time_frame>
    <description>Maximum concentration (Cmax)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough)</measure>
    <time_frame>Day 7 predose; Day10 predose and Day 11 postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of pharmacokinetics of plasma isavuconazole concentration: AUCtau, Cmax, and tmax</measure>
    <time_frame>Day 8 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose; Day 9 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours postdose</time_frame>
    <description>AUC during the time interval between consecutive dosing (AUCtau), Cmax, and time to attain Cmax (tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of pharmacokinetics of plasma prednisone: AUClast, AUCinf, Cmax, tmax, t1/2, Vz/F, and CL/F</measure>
    <time_frame>Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose</time_frame>
    <description>Apparent terminal elimination half life ( t1/2), apparent volume of distribution (Vz/F), and apparent body clearance after oral dosing (CL/F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of pharmacokinetics of plasma prednisolone: t max and t1/2</measure>
    <time_frame>Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy Subjects</condition>
  <condition>Pharmacokinetics of Isavuconazole</condition>
  <condition>Pharmacokinetics of Prednisolone</condition>
  <arm_group>
    <arm_group_label>Isavuconazole and Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of prednisone on Days 1 and 9, isavuconazole 3 times a day (TID) on Days 5-6, isavuconazole once a day (QD) on Days 7-10</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isavuconazole</intervention_name>
    <description>oral</description>
    <arm_group_label>Isavuconazole and Prednisone</arm_group_label>
    <other_name>BAL8557</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>oral</description>
    <arm_group_label>Isavuconazole and Prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18&#xD;
             to 32 kg/m2, inclusive&#xD;
&#xD;
          -  Results for aspartate aminotransferase (ALT) must be ≤ upper limit of normal and total&#xD;
             bilirubin must be ≤ 1.5 mg/dL&#xD;
&#xD;
          -  The female subject agrees to sexual abstinence, or is surgically sterile,&#xD;
             postmenopausal (defined as at least 2 years at Screening without menses), or using a&#xD;
             medically acceptable double barrier method (e.g. spermicide and diaphragm, or&#xD;
             spermicide and condom) to prevent pregnancy and agrees to continue using this method&#xD;
             from Screening until 3 weeks after the follow-up visit at the end of the study; and is&#xD;
             not lactating or pregnant as documented by negative pregnancy tests at Screening and&#xD;
             Day -1&#xD;
&#xD;
          -  The male subject agrees to sexual abstinence, is surgically sterile, or is using a&#xD;
             medically acceptable method to prevent pregnancy and agrees to continue using this&#xD;
             method from Screening until 3 weeks after the follow-up visit at the end of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac&#xD;
             arrhythmia or torsade de pointes, structural heart disease, or family history of Long&#xD;
             QT syndrome (suggested by sudden death or a close relative at a young age due to&#xD;
             possible or probably cardiac causes&#xD;
&#xD;
          -  The subject has a history of tuberculosis or exposure to anyone known or suspected to&#xD;
             have tuberculosis or any illness that might confound the results of the study or pose&#xD;
             additional risk in administering study drug to the subject&#xD;
&#xD;
          -  The subject has a positive result for hepatitis C antibodies, hepatitis B surface&#xD;
             antigen, or QuantiFERON®-TB Gold test at Screening or is known to be positive for&#xD;
             human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  The subject has a known or suspected allergy to any of the components of the trial&#xD;
             products including prednisone or the azole class of compounds, or a history of&#xD;
             multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic&#xD;
             reactions&#xD;
&#xD;
          -  The subject is a smoker (any use of tobacco or nicotine containing products) within 6&#xD;
             months prior to Screening&#xD;
&#xD;
          -  The subject has had treatment with prescription drugs or complementary and alternative&#xD;
             medicines within 14 days prior to Day -1, or over-the-counter medications within 1&#xD;
             week prior to Day -1, with the exception of acetaminophen up to 2 g/day&#xD;
&#xD;
          -  The subject has a recent history (within the last 2 years) of drug or alcohol abuse or&#xD;
             a positive drug and/or alcohol screen&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel International, LLC</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 19, 2012</last_update_submitted>
  <last_update_submitted_qc>October 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>isavuconazole</keyword>
  <keyword>prednisone</keyword>
  <keyword>prednisolone</keyword>
  <keyword>BAL8557</keyword>
  <keyword>healthy volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isavuconazole</mesh_term>
    <mesh_term>Prednisone</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/NCT01711827
org study id: 9766-CL-0024
nct id: NCT01711827
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of prednisolone after single dose administration of prednisone. This study
      will also assess the safety and tolerability of isavuconazole alone and in combination with
      prednisone.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pharmacokinetics of plasma prednisolone: AUClast,
time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
description: Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUC last)
measure: Pharmacokinetics of plasma prednisolone: AUCinf
time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
description: AUC from the time of dosing to infinity (AUCinf),
measure: Pharmacokinetics of plasma prednisolone: Cmax
time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
description: Maximum concentration (Cmax)
measure: Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough)
time frame: Day 7 predose; Day10 predose and Day 11 postdose
measure: Composite of pharmacokinetics of plasma isavuconazole concentration: AUCtau, Cmax, and tmax
time frame: Day 8 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose; Day 9 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours postdose
description: AUC during the time interval between consecutive dosing (AUCtau), Cmax, and time to attain Cmax (tmax)
measure: Composite of pharmacokinetics of plasma prednisone: AUClast, AUCinf, Cmax, tmax, t1/2, Vz/F, and CL/F
time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
description: Apparent terminal elimination half life ( t1/2), apparent volume of distribution (Vz/F), and apparent body clearance after oral dosing (CL/F)
measure: Composite of pharmacokinetics of plasma prednisolone: t max and t1/2
time frame: Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose
measure: Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs
time frame: 18 days
arm group label: Isavuconazole and Prednisone
arm group type: Experimental
description: Single dose of prednisone on Days 1 and 9, isavuconazole 3 times a day (TID) on Days 5-6, isavuconazole once a day (QD) on Days 7-10
intervention type: Drug
intervention name: Isavuconazole
description: oral
arm group label: Isavuconazole and Prednisone
other name: BAL8557
intervention type: Drug
intervention name: Prednisone
description: oral
arm group label: Isavuconazole and Prednisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development
facility: 
country: United States
responsible party type: Sponsor
mesh term: Isavuconazole
mesh term: Prednisone