<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/NCT03762928</url>
  </required_header>
  <id_info>
    <org_study_id>B7981017</org_study_id>
    <nct_id>NCT03762928</nct_id>
  </id_info>
  <brief_title>ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ</brief_title>
  <official_title>A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ 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>
      The current study will estimate any inhibitive or inductive effect of PF-06651600 on the&#xD;
      pharmacokinetics of midazolam and efavirenz.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">February 21, 2019</completion_date>
  <primary_completion_date type="Actual">January 27, 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>single dose Area under the curve at last quantifiable infinity time of midazolam</measure>
    <time_frame>Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz</measure>
    <time_frame>hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of subjects with significant change from baseline in vital signs</measure>
    <time_frame>hour 0 on study days 1, 4, 10 and 13 post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of subjects with significant change from baseline in laboratory safety tests results</measure>
    <time_frame>study days -1, 4, 13 post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of subjects with treatment emergent adverse events (TEAE)</measure>
    <time_frame>Baseline up to 35 days post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>midazolam/efavirenz</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06651600/midazolam/efavirenz</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06651600</intervention_name>
    <description>200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days</description>
    <arm_group_label>PF-06651600/midazolam/efavirenz</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam</intervention_name>
    <description>single administration of midazolam 2 mg oral solution</description>
    <arm_group_label>PF-06651600/midazolam/efavirenz</arm_group_label>
    <arm_group_label>midazolam/efavirenz</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>efavirenz</intervention_name>
    <description>single administration of efavirenz 50 mg capsule</description>
    <arm_group_label>PF-06651600/midazolam/efavirenz</arm_group_label>
    <arm_group_label>midazolam/efavirenz</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male and female participants who are healthy Body mass index (BMI) of 17.5 to 30.5 kg/m2;&#xD;
        and a total body weight &gt;50 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,&#xD;
             dermatological, or allergic disease&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption&#xD;
&#xD;
          -  Known immunodeficiency.&#xD;
&#xD;
          -  Infection with hepatitis B or hepatitis C viruses&#xD;
&#xD;
          -  acute or chronic infections or infection history judged to be clinically significant&#xD;
             by the investigator&#xD;
&#xD;
          -  History of any lymphoproliferative disorder&#xD;
&#xD;
          -  known present or a 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;
&#xD;
          -  live (attenuated) vaccines within 6 weeks prior to the first 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>Pfizer 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=B7981017&amp;StudyName=A+Phase+1%2C+Randomized%2C+Open+Label%2C+2-way+Crossover+Study+To+Estimate+The+Effect+Of+Multiple+Dose+Pf-06651600+On+The+Pharmacokinetics+Of+Single+Dose+Midazolam+And+Efavirenz+In+Healthy+Participants</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PK</keyword>
  <keyword>Phase 1</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Efavirenz</mesh_term>
    <mesh_term>Midazolam</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/NCT03762928
org study id: B7981017
nct id: NCT03762928
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The current study will estimate any inhibitive or inductive effect of PF-06651600 on the
      pharmacokinetics of midazolam and efavirenz.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: single dose Area under the curve at last quantifiable infinity time of midazolam
time frame: Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose
measure: Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz
time frame: hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose
measure: number of subjects with significant change from baseline in vital signs
time frame: hour 0 on study days 1, 4, 10 and 13 post-dose
measure: number of subjects with significant change from baseline in laboratory safety tests results
time frame: study days -1, 4, 13 post-dose
measure: number of subjects with treatment emergent adverse events (TEAE)
time frame: Baseline up to 35 days post dose
arm group label: midazolam/efavirenz
arm group type: Experimental
arm group label: PF-06651600/midazolam/efavirenz
arm group type: Experimental
intervention type: Drug
intervention name: PF-06651600
description: 200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days
arm group label: PF-06651600/midazolam/efavirenz
intervention type: Drug
intervention name: midazolam
description: single administration of midazolam 2 mg oral solution
arm group label: PF-06651600/midazolam/efavirenz
arm group label: midazolam/efavirenz
intervention type: Drug
intervention name: efavirenz
description: single administration of efavirenz 50 mg capsule
arm group label: PF-06651600/midazolam/efavirenz
arm group label: midazolam/efavirenz
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=B7981017&StudyName=A+Phase+1%2C+Randomized%2C+Open+Label%2C+2-way+Crossover+Study+To+Estimate+The+Effect+Of+Multiple+Dose+Pf-06651600+On+The+Pharmacokinetics+Of+Single+Dose+Midazolam+And+Efavirenz+In+Healthy+Participants
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Efavirenz
mesh term: Midazolam
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.