<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/NCT02192294</url>
  </required_header>
  <id_info>
    <org_study_id>B1871044</org_study_id>
    <secondary_id>2014-001405-40</secondary_id>
    <nct_id>NCT02192294</nct_id>
  </id_info>
  <brief_title>Absolute Bioavailability Of Bosutinib</brief_title>
  <official_title>An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In Healthy Subjects</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period&#xD;
      crossover study in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 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>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the Concentration-Time Curve (AUC)</measure>
    <time_frame>96 hours</time_frame>
    <description>AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>96 hours</time_frame>
    <description>Maximum Observed Plasma Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>96 hours</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>96 hours</time_frame>
    <description>Time to Reach Maximum Observed Plasma Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>96 hours</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Clearance (CL)</measure>
    <time_frame>96 hours</time_frame>
    <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution at Steady State (Vss)</measure>
    <time_frame>96 hours</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Bosutinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Bosutinib</intervention_name>
    <description>a single dose of 500 mg oral bosutinib</description>
    <arm_group_label>Bosutinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous infusion of bosutinib</intervention_name>
    <description>a single dose of 120 mg of bosutinib intravenous infusion (1 hour)</description>
    <arm_group_label>Bosutinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects (of non-childbearing potential).&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,&#xD;
             laboratory tests, accept placement of indwelling catheter for infusion and other study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergies).&#xD;
&#xD;
          -  A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids,&#xD;
             benzodiazepines and amphetamines.&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Ruddington Fields</city>
        <state>Nottingham</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871044&amp;StudyName=Absolute%20Bioavailability%20Of%20Bosutinib</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>October 30, 2014</last_update_submitted>
  <last_update_submitted_qc>October 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bosutinib</keyword>
  <keyword>absolute bioavailability</keyword>
  <!-- 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/NCT02192294
org study id: B1871044
secondary id: 2014-001405-40
nct id: NCT02192294
lead sponsor: 
has dmc: No
This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period
      crossover study in healthy subjects.
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the Concentration-Time Curve (AUC)
time frame: 96 hours
description: AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 96 hours
description: Maximum Observed Plasma Concentration
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 96 hours
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 96 hours
description: Time to Reach Maximum Observed Plasma Concentration
measure: Plasma Decay Half-Life (t1/2)
time frame: 96 hours
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Systemic Clearance (CL)
time frame: 96 hours
description: CL is a quantitative measure of the rate at which a drug substance is removed from the body.
measure: Volume of Distribution at Steady State (Vss)
time frame: 96 hours
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
arm group label: Bosutinib
arm group type: Experimental
intervention type: Drug
intervention name: Oral Bosutinib
description: a single dose of 500 mg oral bosutinib
arm group label: Bosutinib
intervention type: Drug
intervention name: Intravenous infusion of bosutinib
description: a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
arm group label: Bosutinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United Kingdom
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871044&StudyName=Absolute%20Bioavailability%20Of%20Bosutinib
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor