<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/NCT03031119</url>
  </required_header>
  <id_info>
    <org_study_id>C1061002</org_study_id>
    <secondary_id>2016-004649-10</secondary_id>
    <nct_id>NCT03031119</nct_id>
  </id_info>
  <brief_title>Multiple Ascending Dose and DDI Study</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Multiple Oral Doses Of Pf-06835919 In Healthy Adult Subjects (Part A); And An Open-label Study To Assess Multiple Oral Doses Of Pf-06835919 On Atorvastatin Pharmacokinetics (Part B)</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for&#xD;
      14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919&#xD;
      co-administration at low and high doses on the PK of atorvastatin in a single cohort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)</measure>
    <time_frame>Screening to Day 24</time_frame>
    <description>Part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities</measure>
    <time_frame>Day -2 to Day 24</time_frame>
    <description>Part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in vital signs</measure>
    <time_frame>Day -1 to Day 24</time_frame>
    <description>Part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in 12-lead electrocardiogram</measure>
    <time_frame>Day -1 to Day 24</time_frame>
    <description>Part A</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day -1 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 3 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 7 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day -1 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 3 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 7 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 3 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Day -1 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Day 3 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Day 7 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) on Day -1 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) on Day 3 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) on Day 7 of atorvastatin and 2 active metabolites</measure>
    <time_frame>0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose</time_frame>
    <description>Part B</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Plasma Trough Concentration (Cmin) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Plasma Trough Concentration (Cmin) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio (Rac) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio (Rac) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Amount of Drug Recovered Unchanged in Urine (Ae) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Cumulative Amount of Drug Recovered Unchanged in Urine (Ae%) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (CLr) on Day 14 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)</measure>
    <time_frame>Screening to Day 18</time_frame>
    <description>Part B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities</measure>
    <time_frame>Day -2 to Day 18</time_frame>
    <description>Part B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Vital Signs</measure>
    <time_frame>Day -2 to Day 18</time_frame>
    <description>Part B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 12-lead electrocardiogram</measure>
    <time_frame>Day -2 to Day 18</time_frame>
    <description>Part B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 7 Part A</measure>
    <time_frame>0,0.5,1,2,4,5,6,8 and 12 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tablets administered once or twice daily, with food, in Part A for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06835919</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablets administered once or twice daily, with food, in Part A for 14 days. Tablets administered once or twice daily, for 4 days at a low dose and for 4 days at a higher dose, with food and atorvastatin in Part B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>atorvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part B, tablets administered once or twice daily, with food, with and without a low dose of PF-06835919 for 4 days and a higher dose of PF-06835919 for 4 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets administered once or twice daily, with food, in Part A.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06835919</intervention_name>
    <description>Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.</description>
    <arm_group_label>PF-06835919</arm_group_label>
    <arm_group_label>atorvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>atorvastatin</intervention_name>
    <description>In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.</description>
    <arm_group_label>PF-06835919</arm_group_label>
    <arm_group_label>atorvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and females (nonchildbearing potential)&#xD;
&#xD;
          -  18 to 55 years old&#xD;
&#xD;
          -  Body Mass Index 17.5 to 30.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hereditary fructose intolerance or fructose malabsorption disorder (Part A)&#xD;
&#xD;
          -  Statin intolerance (Part B)&#xD;
&#xD;
          -  Unable to consume high fructose syrup-containing beverage with each meal while in the&#xD;
             unit (Part A)&#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=C1061002&amp;StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Oral+Doses+Of+Pf-06835919+In+Healthy+Adult+Subjects+%28part+A%29%3B+And+An+Open-label+Study+To+Assess+Multiple+Oral+Doses+Of+Pf-06835919+On+Atorvastatin+Pharmacokinetics+%28part+B%29</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nonalcoholic steatohepatitis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <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/NCT03031119
org study id: C1061002
secondary id: 2016-004649-10
nct id: NCT03031119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for
      14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919
      co-administration at low and high doses on the PK of atorvastatin in a single cohort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
time frame: Screening to Day 24
description: Part A
measure: Number of Participants With Clinical Laboratory Abnormalities
time frame: Day -2 to Day 24
description: Part A
measure: Change from baseline in vital signs
time frame: Day -1 to Day 24
description: Part A
measure: Change from baseline in 12-lead electrocardiogram
time frame: Day -1 to Day 24
description: Part A
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day -1 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 3 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 7 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day -1 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 3 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 7 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 3 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Maximum Observed Plasma Concentration (Cmax) on Day -1 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Maximum Observed Plasma Concentration (Cmax) on Day 3 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Maximum Observed Plasma Concentration (Cmax) on Day 7 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Plasma Decay Half-Life (t1/2) on Day -1 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Plasma Decay Half-Life (t1/2) on Day 3 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Plasma Decay Half-Life (t1/2) on Day 7 of atorvastatin and 2 active metabolites
time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose
description: Part B
measure: Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48, and 72 hours post-dose
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Apparent Oral Clearance (CL/F) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Apparent Oral Clearance (CL/F) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Minimum Observed Plasma Trough Concentration (Cmin) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Minimum Observed Plasma Trough Concentration (Cmin) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Accumulation Ratio (Rac) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Accumulation Ratio (Rac) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
measure: Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Plasma Decay Half-Life (t1/2) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Apparent Volume of Distribution (Vz/F) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Cumulative Amount of Drug Recovered Unchanged in Urine (Ae) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Percent Cumulative Amount of Drug Recovered Unchanged in Urine (Ae%) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Renal Clearance (CLr) on Day 14 Part A
time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
time frame: Screening to Day 18
description: Part B
measure: Number of Participants With Clinical Laboratory Abnormalities
time frame: Day -2 to Day 18
description: Part B
measure: Change from Baseline in Vital Signs
time frame: Day -2 to Day 18
description: Part B
measure: Change from baseline in 12-lead electrocardiogram
time frame: Day -2 to Day 18
description: Part B
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 7 Part A
time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Tablets administered once or twice daily, with food, in Part A for 14 days.
arm group label: PF-06835919
arm group type: Experimental
description: Tablets administered once or twice daily, with food, in Part A for 14 days. Tablets administered once or twice daily, for 4 days at a low dose and for 4 days at a higher dose, with food and atorvastatin in Part B.
arm group label: atorvastatin
arm group type: Experimental
description: In Part B, tablets administered once or twice daily, with food, with and without a low dose of PF-06835919 for 4 days and a higher dose of PF-06835919 for 4 days.
intervention type: Drug
intervention name: Placebo
description: Tablets administered once or twice daily, with food, in Part A.
arm group label: Placebo
intervention type: Drug
intervention name: PF-06835919
description: Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.
arm group label: PF-06835919
arm group label: atorvastatin
intervention type: Drug
intervention name: atorvastatin
description: In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.
arm group label: PF-06835919
arm group label: atorvastatin
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=C1061002&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Oral+Doses+Of+Pf-06835919+In+Healthy+Adult+Subjects+%28part+A%29%3B+And+An+Open-label+Study+To+Assess+Multiple+Oral+Doses+Of+Pf-06835919+On+Atorvastatin+Pharmacokinetics+%28part+B%29
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Atorvastatin
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