<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/NCT03270878</url>
  </required_header>
  <id_info>
    <org_study_id>B1371022</org_study_id>
    <nct_id>NCT03270878</nct_id>
  </id_info>
  <brief_title>Glasdegib Absolute Bioavailability Study</brief_title>
  <official_title>A Phase One, Single Dose, Randomized, Open-label, Two-period, Two-sequence, Crossover, Absolute Bioavailability Study Of Glasdegib (Pf-04449913) In Healthy Volunteers</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>
      This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of&#xD;
      the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet&#xD;
      vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 6, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteer Study</condition>
  <arm_group>
    <arm_group_label>Glasdegib Oral tablet then IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions in the first study period followed by washout. Then in the second period, a 50 mg IV solution will be infused over approximately 1.25 hours under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glasdegib IV solution followed by Oral tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a 50 mg IV solution will be infused over approximately 1.25 hours in the fasted condition followed by washout in the first study period . Then in the second period, a single 100 mg oral tablet of glasdegib will be administered under fasted conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glasdegib Oral Tablet</intervention_name>
    <description>Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions, either in study period 1 or 2, depending on randomization.</description>
    <arm_group_label>Glasdegib IV solution followed by Oral tablet</arm_group_label>
    <arm_group_label>Glasdegib Oral tablet then IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glasdegib IV infusion</intervention_name>
    <description>Subjects will receive a 50 mg IV infusion of glasdegib over approximately 1.25 hours, in the fasted state, in either period 1 or 2 based on randomization.</description>
    <arm_group_label>Glasdegib IV solution followed by Oral tablet</arm_group_label>
    <arm_group_label>Glasdegib Oral tablet then IV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects of non-child bearing potential who, at the time of&#xD;
             screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as&#xD;
             no clinically relevant abnormalities identified by a detailed medical history, full&#xD;
             physical examination, including blood pressure and pulse rate measurement, 12-lead ECG&#xD;
             or clinical laboratory tests. Female subjects of nonchildbearing potential must meet&#xD;
             at least 1 of the following criteria:&#xD;
&#xD;
               1. Achieved postmenopausal status, defined as follows: cessation of regular menses&#xD;
                  for at least 24 consecutive months with no alternative pathological or&#xD;
                  physiological cause; with a serum follicle-stimulating hormone (FSH) level&#xD;
                  confirming the postmenopausal state;&#xD;
&#xD;
               2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;&#xD;
&#xD;
               3. Have medically confirmed ovarian failure. All other female subjects (including&#xD;
                  females with tubal ligations and females that do NOT have a documented&#xD;
                  hysterectomy, bilateral oophorectomy and/or ovarian failure) are considered to be&#xD;
                  of childbearing potential.&#xD;
&#xD;
          -  Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lb).&#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. -. Subjects who&#xD;
             are willing and able to comply with all scheduled visits, treatment plan, laboratory&#xD;
             tests, and other study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -A positive urine drug test.&#xD;
&#xD;
          -  Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval &gt;450 msec or&#xD;
             a QRS interval &gt;120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG&#xD;
             should be repeated 2 more times and the average of the 3 QTc or QRS values should be&#xD;
             used to determine the subject's eligibility.&#xD;
&#xD;
          -  Subjects with family history of myocardial infarction, congenital long QT syndrome,&#xD;
             torsades de pointes or clinically significant ventricular arrhythmias. Subjects should&#xD;
             be within normal range of potassium, magnesium and corrected calcium calculation at&#xD;
             screening.&#xD;
&#xD;
          -  Pregnant female subjects; breastfeeding female subjects; female subjects of&#xD;
             childbearing potential; male subjects with partners currently pregnant; male subjects&#xD;
             who are unwilling or unable to use two highly effective methods of contraception as&#xD;
             outlined in this protocol for the duration of the study and for at least 90 days after&#xD;
             the last dose of investigational product and, refrain from sperm donation for the&#xD;
             duration of the Study and for at least 90 days after the last dose of investigational&#xD;
             product.&#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>New Haven Clinical Research Unit</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371022&amp;StudyName=A+Phase+One%2C+Single+Dose%2C+Randomized%2C+Open-label%2C+Two-period%2C+Two-sequence%2C+Crossover%2C+Absolute+Bioavailability+Study+Of+Glasdegib+%28pf-04449913%29+In+Healthy+Volunteers</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>November 2, 2017</last_update_submitted>
  <last_update_submitted_qc>November 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glasdegib</keyword>
  <keyword>PF-04449913</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Bioavailability</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests</ipd_description>
  </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/NCT03270878
org study id: B1371022
nct id: NCT03270878
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of
      the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet
      vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy
      volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
time frame: 5 days
arm group label: Glasdegib Oral tablet then IV
arm group type: Experimental
description: Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions in the first study period followed by washout. Then in the second period, a 50 mg IV solution will be infused over approximately 1.25 hours under fasted conditions.
arm group label: Glasdegib IV solution followed by Oral tablet
arm group type: Experimental
description: Subjects will receive a 50 mg IV solution will be infused over approximately 1.25 hours in the fasted condition followed by washout in the first study period . Then in the second period, a single 100 mg oral tablet of glasdegib will be administered under fasted conditions
intervention type: Drug
intervention name: Glasdegib Oral Tablet
description: Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions, either in study period 1 or 2, depending on randomization.
arm group label: Glasdegib IV solution followed by Oral tablet
arm group label: Glasdegib Oral tablet then IV
intervention type: Drug
intervention name: Glasdegib IV infusion
description: Subjects will receive a 50 mg IV infusion of glasdegib over approximately 1.25 hours, in the fasted state, in either period 1 or 2 based on randomization.
arm group label: Glasdegib IV solution followed by Oral tablet
arm group label: Glasdegib Oral tablet then IV
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 States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371022&StudyName=A+Phase+One%2C+Single+Dose%2C+Randomized%2C+Open-label%2C+Two-period%2C+Two-sequence%2C+Crossover%2C+Absolute+Bioavailability+Study+Of+Glasdegib+%28pf-04449913%29+In+Healthy+Volunteers
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: No
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests