<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/NCT03821493</url>
  </required_header>
  <id_info>
    <org_study_id>B7981023</org_study_id>
    <secondary_id>2018-004664-55</secondary_id>
    <nct_id>NCT03821493</nct_id>
  </id_info>
  <brief_title>Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants</brief_title>
  <official_title>A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06651600 IN HEALTHY PARTICIPANTS</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 will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the&#xD;
      pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.&#xD;
&#xD;
      This is an open-label, fixed sequence two period study with healthy participants that will&#xD;
      receive a single dose of PF-06651600 alone and co-administered with multiple doses of&#xD;
      itraconazole at a single center.&#xD;
&#xD;
      Participants will be screened within 28 days of the first dose of the investigational&#xD;
      products and if entry criteria are met, the participant will report to the clinic on the day&#xD;
      before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of&#xD;
      PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will&#xD;
      receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive&#xD;
      30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after&#xD;
      the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The&#xD;
      participant will be followed up by phone contact.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">June 4, 2019</completion_date>
  <primary_completion_date type="Actual">April 6, 2019</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration of PF-06651600</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours</time_frame>
    <description>Peak concentration of PF-06651600</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (AEs)</measure>
    <time_frame>Baseline up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events leading to discontinuation</measure>
    <time_frame>Baseline up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant change in vital signs from Baseline</measure>
    <time_frame>Baseline to Day 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant abnormalities in clinical laboratory values</measure>
    <time_frame>Baseline to Day 9</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>PF-06651600 treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06651600 10 mg tablets</intervention_name>
    <description>On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.&#xD;
On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.</description>
    <arm_group_label>PF-06651600 treatment arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole Solution 200 mg</intervention_name>
    <description>Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.&#xD;
On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.</description>
    <arm_group_label>PF-06651600 treatment arm</arm_group_label>
    <other_name>Sporanox Oral Solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to comply with all scheduled visits, treatment plan, laboratory&#xD;
             tests, lifestyle considerations and other study procedures.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of congestive heart failure or history of congestive heart failure or any of&#xD;
             the following: myocardial infarction, severe/unstable angina, coronary/peripheral&#xD;
             artery bypass graft, cerebrovascular accident including transient ischemic attack or&#xD;
             pulmonary embolus.&#xD;
&#xD;
          -  Known hypersensitivity to itraconazole or it excipients or to other azole antifungals.&#xD;
&#xD;
          -  Infection with Hepatitis B, C or HIV&#xD;
&#xD;
          -  Known present or history of malignancy other than a successfully treated or excised&#xD;
             non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in&#xD;
             situ.&#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>Pfizer Clinical Research Unit</name>
      <address>
        <city>Brussels</city>
        <state>Be-bru</state>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981023&amp;StudyName=A+PHASE+1%2C+OPEN-LABEL%2C+FIXED+SEQUENCE+2-PERIOD+STUDY+TO+INVESTIGATE+THE+EFFECT+OF+MULTIPLE+DOSES+OF+ITRACONAZOLE+ON+THE+PHARMACOKINETICS+OF+A+SINGLE+DOSE+OF+PF-06651600+IN+HEALTHY+PARTICIPANTS</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>June 27, 2019</last_update_submitted>
  <last_update_submitted_qc>June 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PF-06651600</keyword>
  <keyword>Itraconazole</keyword>
  <keyword>CYP3A4</keyword>
  <keyword>Drug-Drug Interaction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/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/NCT03821493
org study id: B7981023
secondary id: 2018-004664-55
nct id: NCT03821493
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the
      pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.

      This is an open-label, fixed sequence two period study with healthy participants that will
      receive a single dose of PF-06651600 alone and co-administered with multiple doses of
      itraconazole at a single center.

      Participants will be screened within 28 days of the first dose of the investigational
      products and if entry criteria are met, the participant will report to the clinic on the day
      before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of
      PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will
      receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive
      30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after
      the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The
      participant will be followed up by phone contact.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
description: Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity.
measure: Maximum observed plasma concentration of PF-06651600
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
description: Peak concentration of PF-06651600
measure: Incidence of treatment-emergent adverse events (AEs)
time frame: Baseline up to 35 days
measure: Number of adverse events leading to discontinuation
time frame: Baseline up to 35 days
measure: Number of participants with clinically significant change in vital signs from Baseline
time frame: Baseline to Day 9
measure: Number of participants with clinically significant abnormalities in clinical laboratory values
time frame: Baseline to Day 9
arm group label: PF-06651600 treatment arm
arm group type: Experimental
description: This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole
intervention type: Drug
intervention name: PF-06651600 10 mg tablets
description: On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.
On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.
arm group label: PF-06651600 treatment arm
intervention type: Drug
intervention name: Itraconazole Solution 200 mg
description: Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.
On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.
arm group label: PF-06651600 treatment arm
other name: Sporanox Oral Solution
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: Belgium
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981023&StudyName=A+PHASE+1%2C+OPEN-LABEL%2C+FIXED+SEQUENCE+2-PERIOD+STUDY+TO+INVESTIGATE+THE+EFFECT+OF+MULTIPLE+DOSES+OF+ITRACONAZOLE+ON+THE+PHARMACOKINETICS+OF+A+SINGLE+DOSE+OF+PF-06651600+IN+HEALTHY+PARTICIPANTS
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Itraconazole
mesh term: Pharmaceutical Solutions
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.