<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/NCT01707082</url>
  </required_header>
  <id_info>
    <org_study_id>B5211002</org_study_id>
    <nct_id>NCT01707082</nct_id>
  </id_info>
  <brief_title>A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults</brief_title>
  <acronym>B521MAD</acronym>
  <official_title>A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part A of the study will test the safety, the amount of drug in the body, and effects of the&#xD;
      drug in the body after multiple doses. This will be conducted in healthy overweight adults.&#xD;
      Part B of the study will test the effects of multiple doses of the investigational drug on&#xD;
      the amount of midazolam, an approved drug, in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve from Time Zero to end of dosing interval (AUCtau)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Oral Clearance (CL/F)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve from Time Zero to end of dosing interval (AUCtau)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum Observed Plasma Trough Concentration (Cmin)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Oral Clearance (CL/F)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B</time_frame>
    <description>AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]</measure>
    <time_frame>-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B</time_frame>
    <description>AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>-2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Concentration (Cav)</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Accumulation Ratio</measure>
    <time_frame>Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A</time_frame>
    <description>Mean 24-hour average diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A</time_frame>
    <description>Mean 24-hour average diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A</time_frame>
    <description>Mean 24-hour average systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A</time_frame>
    <description>Mean 24-hour average systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6</measure>
    <time_frame>Days 1 and 14 pre-dose Part A</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>high-sensitivity C-reactive protein</measure>
    <time_frame>Days 1 and 14 pre-dose Part A</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total cholesterol, HDL-C, triglycerides and calculated LDL-C</measure>
    <time_frame>Days 1 and 14 pre-dose Part A</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ApoBTotal,ApoB48, ApoB100, ApoA-1</measure>
    <time_frame>Days 1 and 14 pre-dose Part A</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B</time_frame>
    <description>Mean 24-hour average diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B</time_frame>
    <description>Mean 24-hour average diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B</time_frame>
    <description>Mean 24-hour average systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B</time_frame>
    <description>Mean 24-hour average systolic blood pressure</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, 10 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet, 0 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, 30 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet, 0 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, 100 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet, 0 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, 250 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet, 0 mg, every 8 hours, 14 days</description>
    <arm_group_label>Part A Cohort 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days</description>
    <arm_group_label>Part A Cohort 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet, 0 mg, every 8 or 12 hours, 14 days</description>
    <arm_group_label>Part A Cohort 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam</intervention_name>
    <description>Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14</description>
    <arm_group_label>Part B Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days</description>
    <arm_group_label>Part B Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam</intervention_name>
    <description>Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14</description>
    <arm_group_label>Part B Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06282999</intervention_name>
    <description>Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days</description>
    <arm_group_label>Part B Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive&#xD;
             (Healthy is defined as no clinically relevant abnormalities identified by a detailed&#xD;
             medical history, full physical examination, including blood pressure and pulse rate&#xD;
             measurement, 12-lead ECG and clinical laboratory tests). Women must be of non&#xD;
             childbearing potential.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B);&#xD;
             and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
        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 clinically significant drug allergies, but excluding&#xD;
             untreated, asymptomatic, seasonal allergies at time of dosing).&#xD;
&#xD;
          -  Subject with any contraindication to midazolam according to the country specific&#xD;
             labeling or subject with previous intolerance or allergy to benzodiazepines&#xD;
             (applicable to Part B of study only).&#xD;
&#xD;
          -  Subjects who were enrolled in Part A are excluded from participation in Part B of this&#xD;
             study.&#xD;
&#xD;
          -  Subjects who have previously participated in a study with PF-06282999.&#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 Investigational Site</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=B5211002&amp;StudyName=A%20Study%20To%20Test%20The%20Safety%2C%20Amount%20And%20Effects%20Of%20PF-06282999%20In%20Healthy%20Overweight%20Adults%20And%20A%20Study%20To%20Test%20The%20Effects%20Of%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>July 29, 2013</last_update_submitted>
  <last_update_submitted_qc>July 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2013</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01707082
org study id: B5211002
nct id: NCT01707082
lead sponsor: 
has dmc: No
Part A of the study will test the safety, the amount of drug in the body, and effects of the
      drug in the body after multiple doses. This will be conducted in healthy overweight adults.
      Part B of the study will test the effects of multiple doses of the investigational drug on
      the amount of midazolam, an approved drug, in healthy adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
measure: Apparent Oral Clearance (CL/F)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Minimum Observed Plasma Trough Concentration (Cmin)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Apparent Oral Clearance (CL/F)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Plasma Decay Half-Life (t1/2)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
time frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
description: AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
time frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
description: AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
measure: Average Concentration (Cav)
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Accumulation Ratio
time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
measure: Diastolic Blood Pressure
time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
description: Mean 24-hour average diastolic blood pressure
measure: Diastolic Blood Pressure
time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
description: Mean 24-hour average diastolic blood pressure
measure: Systolic Blood Pressure
time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
description: Mean 24-hour average systolic blood pressure
measure: Systolic Blood Pressure
time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
description: Mean 24-hour average systolic blood pressure
measure: interleukin-6
time frame: Days 1 and 14 pre-dose Part A
measure: high-sensitivity C-reactive protein
time frame: Days 1 and 14 pre-dose Part A
measure: total cholesterol, HDL-C, triglycerides and calculated LDL-C
time frame: Days 1 and 14 pre-dose Part A
measure: ApoBTotal,ApoB48, ApoB100, ApoA-1
time frame: Days 1 and 14 pre-dose Part A
measure: Diastolic Blood Pressure
time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
description: Mean 24-hour average diastolic blood pressure
measure: Diastolic Blood Pressure
time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
description: Mean 24-hour average diastolic blood pressure
measure: Systolic Blood Pressure
time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
description: Mean 24-hour average systolic blood pressure
measure: Systolic Blood Pressure
time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
description: Mean 24-hour average systolic blood pressure
arm group label: Part A Cohort 1
arm group type: Experimental
arm group label: Part A Cohort 2
arm group type: Experimental
arm group label: Part A Cohort 3
arm group type: Experimental
arm group label: Part A Cohort 4
arm group type: Experimental
arm group label: Part A Cohort 5
arm group type: Experimental
arm group label: Part B Cohort 1
arm group type: Experimental
arm group label: Part B Cohort 2
arm group type: Experimental
intervention type: Drug
intervention name: PF-06282999
description: Tablet, 10 mg, every 8 hours, 14 days
arm group label: Part A Cohort 1
intervention type: Drug
intervention name: Placebo
description: Tablet, 0 mg, every 8 hours, 14 days
arm group label: Part A Cohort 1
intervention type: Drug
intervention name: PF-06282999
description: Tablet, 30 mg, every 8 hours, 14 days
arm group label: Part A Cohort 2
intervention type: Drug
intervention name: Placebo
description: Tablet, 0 mg, every 8 hours, 14 days
arm group label: Part A Cohort 2
intervention type: Drug
intervention name: PF-06282999
description: Tablet, 100 mg, every 8 hours, 14 days
arm group label: Part A Cohort 3
intervention type: Drug
intervention name: Placebo
description: Tablet, 0 mg, every 8 hours, 14 days
arm group label: Part A Cohort 3
intervention type: Drug
intervention name: PF-06282999
description: Tablet, 250 mg, every 8 hours, 14 days
arm group label: Part A Cohort 4
intervention type: Drug
intervention name: Placebo
description: Tablet, 0 mg, every 8 hours, 14 days
arm group label: Part A Cohort 4
intervention type: Drug
intervention name: PF-06282999
description: Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
arm group label: Part A Cohort 5
intervention type: Drug
intervention name: Placebo
description: Tablet, 0 mg, every 8 or 12 hours, 14 days
arm group label: Part A Cohort 5
intervention type: Drug
intervention name: midazolam
description: Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
arm group label: Part B Cohort 1
intervention type: Drug
intervention name: PF-06282999
description: Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
arm group label: Part B Cohort 1
intervention type: Drug
intervention name: midazolam
description: Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
arm group label: Part B Cohort 2
intervention type: Drug
intervention name: PF-06282999
description: Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
arm group label: Part B Cohort 2
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=B5211002&StudyName=A%20Study%20To%20Test%20The%20Safety%2C%20Amount%20And%20Effects%20Of%20PF-06282999%20In%20Healthy%20Overweight%20Adults%20And%20A%20Study%20To%20Test%20The%20Effects%20Of%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Overweight
mesh term: Midazolam