<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/NCT03230383</url>
  </required_header>
  <id_info>
    <org_study_id>C2541002</org_study_id>
    <secondary_id>2017-001649-28</secondary_id>
    <nct_id>NCT03230383</nct_id>
  </id_info>
  <brief_title>A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be an investigator- and subject-blinded (sponsor open), randomized, placebo&#xD;
      controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional&#xD;
      sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts),&#xD;
      and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each&#xD;
      cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10&#xD;
      subjects dosed in each cohort.&#xD;
&#xD;
      For a given subject in any cohort, the total study duration from screening to follow-up phone&#xD;
      call will be between approximately 7 to 11 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 3, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events (AEs)</measure>
    <time_frame>Baseline up to 35 days after last dose of study medication</time_frame>
    <description>Number of participants with reported adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with laboratory tests findings of potential clinical importance</measure>
    <time_frame>Baseline (Day 0) up to 24 days after last dose of study medication</time_frame>
    <description>Number of participants with potentially clinically important laboratory test findings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with electrocardiogram (ECG) findings of potential clinical importance</measure>
    <time_frame>Baseline (Day 0) up to 24 days after last dose of study medication</time_frame>
    <description>Number of participants with potentially clinically important ECG findings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with vital signs findings of potential clinical importance</measure>
    <time_frame>Baseline (Day 0) up to 24 days after last dose of study medication</time_frame>
    <description>Number of participants with potentially clinically important vital sign measurements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14</time_frame>
    <description>Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Concentration for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14</time_frame>
    <description>Time to Reach Maximum Observed Plasma Concentration (Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose normalized Cmax for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14</time_frame>
    <description>Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14</time_frame>
    <description>Sum of [urine concentration * sample volume] for each collection over the dosing interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14</time_frame>
    <description>100* Aetau/Dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLr) for PF-06865571</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14</time_frame>
    <description>Aetau/AUCtau</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Cohort 1_90mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2_300mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3_900mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4_1800mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5_3000mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Optional Cohort 6_TBD mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Optional Cohort 7_TBD mg and Matching Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Cohort 1_90mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Cohort 2_300mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Cohort 3_900mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Cohort 4_1800mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Cohort 5_3000mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Optional Cohort 6_TBD mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06865571</intervention_name>
    <description>Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.</description>
    <arm_group_label>Optional Cohort 7_TBD mg and Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo for PF-06865571 for each cohort.</description>
    <arm_group_label>Cohort 1_90mg and Matching Placebo</arm_group_label>
    <arm_group_label>Cohort 2_300mg and Matching Placebo</arm_group_label>
    <arm_group_label>Cohort 3_900mg and Matching Placebo</arm_group_label>
    <arm_group_label>Cohort 4_1800mg and Matching Placebo</arm_group_label>
    <arm_group_label>Cohort 5_3000mg and Matching Placebo</arm_group_label>
    <arm_group_label>Optional Cohort 6_TBD mg and Matching Placebo</arm_group_label>
    <arm_group_label>Optional Cohort 7_TBD mg and Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and female of non-childbearing potential;&#xD;
&#xD;
          -  Age of 18-55, inclusive;&#xD;
&#xD;
          -  Body Mass Index 22.5 to 35.4 kg/m2, inclusive;&#xD;
&#xD;
          -  Body weight greater than 50 kg;&#xD;
&#xD;
          -  Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior&#xD;
             to first dose.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergises, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing);&#xD;
&#xD;
          -  Subjects with fasting LDL-C level &gt;190 mg/dL following an overnight fast of at least&#xD;
             10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.&#xD;
&#xD;
          -  Subjects with fasting TG level &gt;400 mg/dL following an overnight fast of at least 10&#xD;
             hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  A positive urine drug test.&#xD;
&#xD;
          -  History of regular alcohol consumption exceeding 7 drinks/week for female subjects or&#xD;
             14 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces&#xD;
             [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before&#xD;
             screening.&#xD;
&#xD;
          -  Treatment with an investigational drug within 30 days (or as determined by the local&#xD;
             requirement) or 5 half lives preceding the first dose of investigational product&#xD;
             (whichever is longer).&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products in excess of the equivalent of 5&#xD;
             cigarettes per day or 2 chews of tobacco per day.&#xD;
&#xD;
          -  Pregnant female subjects; breastfeeding female subjects; male subjects with partners&#xD;
             currently pregnant; fertile male subjects 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;
          -  Unwilling or unable to comply with the criteria in the Lifestyle Requirements section&#xD;
             of this protocol.&#xD;
&#xD;
          -  Other acute or chronic medical or psychiatric condition including recent (within the&#xD;
             past year) or active suicidal ideation or behavior or laboratory abnormality that may&#xD;
             increase the risk associated with study participation or investigational product&#xD;
             administration or may interfere with the interpretation of study results and, in the&#xD;
             judgment of the investigator, would make the subject inappropriate for entry into this&#xD;
             study.&#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>
    <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>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C2541002&amp;StudyName=A+Phase+1%2C+Randomized%2C+Double+Blind%2C+Placebo+Controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Escalating+Oral+Doses+Of+Pf+06865571+In+Otherwise+Healthy%2C+Adult+Subjects</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=C2541002&amp;StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Escalating+Oral+Doses+Of+Pf-06865571+In+Healthy%2C+Including+Overweight+And+Obese%2C+Adult+Subjects</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 21, 2018</last_update_submitted>
  <last_update_submitted_qc>May 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_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/NCT03230383
org study id: C2541002
secondary id: 2017-001649-28
nct id: NCT03230383
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This will be an investigator- and subject-blinded (sponsor open), randomized, placebo
      controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional
      sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts),
      and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each
      cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10
      subjects dosed in each cohort.

      For a given subject in any cohort, the total study duration from screening to follow-up phone
      call will be between approximately 7 to 11 weeks.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of subjects with adverse events (AEs)
time frame: Baseline up to 35 days after last dose of study medication
description: Number of participants with reported adverse events
measure: Number of subjects with laboratory tests findings of potential clinical importance
time frame: Baseline (Day 0) up to 24 days after last dose of study medication
description: Number of participants with potentially clinically important laboratory test findings
measure: Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
time frame: Baseline (Day 0) up to 24 days after last dose of study medication
description: Number of participants with potentially clinically important ECG findings
measure: Number of subjects with vital signs findings of potential clinical importance
time frame: Baseline (Day 0) up to 24 days after last dose of study medication
description: Number of participants with potentially clinically important vital sign measurements
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
measure: AUCtau for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
description: Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state.
measure: Time to Reach Maximum Observed Concentration for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
description: Time to Reach Maximum Observed Plasma Concentration (Tmax)
measure: Dose normalized Cmax for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
description: Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design.
measure: Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
description: Sum of [urine concentration * sample volume] for each collection over the dosing interval
measure: Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
description: 100* Aetau/Dose
measure: Renal clearance (CLr) for PF-06865571
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
description: Aetau/AUCtau
arm group label: Cohort 1_90mg and Matching Placebo
arm group type: Experimental
arm group label: Cohort 2_300mg and Matching Placebo
arm group type: Experimental
arm group label: Cohort 3_900mg and Matching Placebo
arm group type: Experimental
arm group label: Cohort 4_1800mg and Matching Placebo
arm group type: Experimental
arm group label: Cohort 5_3000mg and Matching Placebo
arm group type: Experimental
arm group label: Optional Cohort 6_TBD mg and Matching Placebo
arm group type: Experimental
arm group label: Optional Cohort 7_TBD mg and Matching Placebo
arm group type: Experimental
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Cohort 1_90mg and Matching Placebo
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Cohort 2_300mg and Matching Placebo
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Cohort 3_900mg and Matching Placebo
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Cohort 4_1800mg and Matching Placebo
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Cohort 5_3000mg and Matching Placebo
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Optional Cohort 6_TBD mg and Matching Placebo
intervention type: Drug
intervention name: PF-06865571
description: Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
arm group label: Optional Cohort 7_TBD mg and Matching Placebo
intervention type: Drug
intervention name: Placebo
description: Matching Placebo for PF-06865571 for each cohort.
arm group label: Cohort 1_90mg and Matching Placebo
arm group label: Cohort 2_300mg and Matching Placebo
arm group label: Cohort 3_900mg and Matching Placebo
arm group label: Cohort 4_1800mg and Matching Placebo
arm group label: Cohort 5_3000mg and Matching Placebo
arm group label: Optional Cohort 6_TBD mg and Matching Placebo
arm group label: Optional Cohort 7_TBD mg and Matching Placebo
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: 
facility: 
country: Belgium
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C2541002&StudyName=A+Phase+1%2C+Randomized%2C+Double+Blind%2C+Placebo+Controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Escalating+Oral+Doses+Of+Pf+06865571+In+Otherwise+Healthy%2C+Adult+Subjects
description: To obtain contact information for a study center near you, click here.
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C2541002&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Escalating+Oral+Doses+Of+Pf-06865571+In+Healthy%2C+Including+Overweight+And+Obese%2C+Adult+Subjects
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Overweight
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