<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/NCT03765554</url>
  </required_header>
  <id_info>
    <org_study_id>B7931010</org_study_id>
    <secondary_id>2018-003512-41</secondary_id>
    <nct_id>NCT03765554</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations</brief_title>
  <official_title>A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE TABLETS COMPARED TO IMMEDIATE RELEASE TABLETS UNDER FASTED CONDITIONS</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being&#xD;
      developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This&#xD;
      open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral&#xD;
      doses of immediate release (IR) and modified release (MR) tablets in healthy, adult&#xD;
      participants under fasted conditions. This is an open label, single dose, randomized, 2&#xD;
      period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">April 3, 2019</completion_date>
  <primary_completion_date type="Actual">April 3, 2019</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>Maximum Observed Plasma Concentration (Cmax) of PF-06700841</measure>
    <time_frame>pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841</measure>
    <time_frame>pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach maximum observed plasma concentration (Tmax) of PF-06700841</measure>
    <time_frame>pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit</measure>
    <time_frame>pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval</measure>
    <time_frame>Pre-dose and 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in heart rate</measure>
    <time_frame>Pre-dose and 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in blood pressure</measure>
    <time_frame>Pre-dose and 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pulse rate</measure>
    <time_frame>Pre-dose and 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in oral temperature</measure>
    <time_frame>Pre-dose and 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with laboratory abnormalities</measure>
    <time_frame>Baseline and 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Treatment -Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs</measure>
    <time_frame>Baseline to 48 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>PF-06700841: IR followed by MR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06700841: MR followed by IR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06700841 Immediate release tablets</intervention_name>
    <description>Small molecule tablets in immediate release form</description>
    <arm_group_label>PF-06700841: IR followed by MR</arm_group_label>
    <arm_group_label>PF-06700841: MR followed by IR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06700841 Modified release tablets</intervention_name>
    <description>Small molecule tablets in modified release form</description>
    <arm_group_label>PF-06700841: IR followed by MR</arm_group_label>
    <arm_group_label>PF-06700841: MR followed by IR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male, and female participants between the ages of 18 and 55 years at the time&#xD;
             of screening, inclusive (Healthy is defined as no clinically relevant abnormalities&#xD;
             identified by a detailed medical history, full physical examination, including blood&#xD;
             pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).&#xD;
&#xD;
          -  Participants who are willing and able to comply with all scheduled visits, treatment&#xD;
             plan, laboratory 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 (110 lbs).&#xD;
&#xD;
        Key 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, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing).&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  Have or have had clinically significant infections within the past 3 months prior to&#xD;
             the first dose of investigational product (eg, those requiring hospitalization or&#xD;
             parenteral antibiotics, or as judged by the Investigator), evidence of any infection&#xD;
             within the past 7 days prior to the first dose of investigational product, herpes&#xD;
             simplex within 12 weeks or history of disseminated herpes simplex infection,&#xD;
             symptomatic herpes zoster or recurrent (&gt;1 episode) or disseminated herpes zoster.&#xD;
&#xD;
          -  History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive&#xD;
             testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody&#xD;
             (HepBcAb) or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B&#xD;
             surface antibody (HepBsAb) finding as a result of participant vaccination is&#xD;
             permissible.&#xD;
&#xD;
          -  History of tuberculosis or active or latent or inadequately treated infection,&#xD;
             positive QuantiFERON tuberculosis (TB) Gold test.&#xD;
&#xD;
          -  Previous administration with an investigational drug within 30 days (or as determined&#xD;
             by the local requirement) or 5 half lives preceding the first dose of investigational&#xD;
             product used in this study (whichever is longer).&#xD;
&#xD;
          -  Female participants who are pregnant or wish to become pregnant; breastfeeding&#xD;
             females.&#xD;
&#xD;
          -  Males/Females of childbearing potential who are unwilling or unable to use a highly&#xD;
             effective method of contraception as outlined in this protocol for the duration of the&#xD;
             study and for at least 28 days after the last dose of investigational product.&#xD;
&#xD;
          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 56 days prior to dosing.&#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>
        <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=B7931010&amp;StudyName=A+Phase+1%2C+Open+Label+Study+In+Healthy+Participants+To+Investigate+The+Pharmacokinetics+Of+Pf+06700841+Following+Single+Oral+Administration+Of+Modified+Release+Tablets+Compared+To+Immediate+Release+Tablets+Under+Fasted+Conditions</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7931010&amp;StudyName=A+Phase+1%2C+Open-label+Study+In+Healthy+Participants+To+Investigate+The+Pharmacokinetics+Of+Pf-06700841+Following+Single+Oral+Administration+Of+Modified+Release+Tablets+Compared+To+Immediate+Release+Tablets+Under+Fasted+Conditions</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PF-06700841</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/NCT03765554
org study id: B7931010
secondary id: 2018-003512-41
nct id: NCT03765554
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being
      developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This
      open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral
      doses of immediate release (IR) and modified release (MR) tablets in healthy, adult
      participants under fasted conditions. This is an open label, single dose, randomized, 2
      period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy
      participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
measure: Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841
time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
measure: Time to reach maximum observed plasma concentration (Tmax) of PF-06700841
time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
measure: Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit
time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
measure: Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval
time frame: Pre-dose and 48 hours post-dose
measure: Change from baseline in heart rate
time frame: Pre-dose and 48 hours post-dose
measure: Change from baseline in blood pressure
time frame: Pre-dose and 48 hours post-dose
measure: Change from baseline in pulse rate
time frame: Pre-dose and 48 hours post-dose
measure: Change from baseline in oral temperature
time frame: Pre-dose and 48 hours post-dose
measure: Number of participants with laboratory abnormalities
time frame: Baseline and 48 hours post-dose
measure: Number of participants with Treatment -Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
time frame: Baseline to 48 hours post-dose
arm group label: PF-06700841: IR followed by MR
arm group type: Experimental
description: Participants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR)
arm group label: PF-06700841: MR followed by IR
arm group type: Experimental
description: Participants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR)
intervention type: Drug
intervention name: PF-06700841 Immediate release tablets
description: Small molecule tablets in immediate release form
arm group label: PF-06700841: IR followed by MR
arm group label: PF-06700841: MR followed by IR
intervention type: Drug
intervention name: PF-06700841 Modified release tablets
description: Small molecule tablets in modified release form
arm group label: PF-06700841: IR followed by MR
arm group label: PF-06700841: MR followed by IR
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=B7931010&StudyName=A+Phase+1%2C+Open+Label+Study+In+Healthy+Participants+To+Investigate+The+Pharmacokinetics+Of+Pf+06700841+Following+Single+Oral+Administration+Of+Modified+Release+Tablets+Compared+To+Immediate+Release+Tablets+Under+Fasted+Conditions
description: To obtain contact information for a study center near you, click here.
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7931010&StudyName=A+Phase+1%2C+Open-label+Study+In+Healthy+Participants+To+Investigate+The+Pharmacokinetics+Of+Pf-06700841+Following+Single+Oral+Administration+Of+Modified+Release+Tablets+Compared+To+Immediate+Release+Tablets+Under+Fasted+Conditions
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: PF-06700841
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.