<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/NCT03020784</url>
  </required_header>
  <id_info>
    <org_study_id>C0601001</org_study_id>
    <nct_id>NCT03020784</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of PF-06818883 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single-ascending Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-06818883 Following Single Intravenous Administration In Healthy 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>
      Safety, Tolerability and Pharmacokinetics of PF-06818883&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated on 16JUN2017 for safety reasons&#xD;
  </why_stopped>
  <start_date type="Actual">November 11, 2016</start_date>
  <completion_date type="Actual">June 13, 2017</completion_date>
  <primary_completion_date type="Actual">June 13, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Day 0, Day 1, Day 2, Day 3</time_frame>
    <description>An assessment of Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Physical examination</measure>
    <time_frame>Day 0, Day 1, Day 2 and Day 3</time_frame>
    <description>Safety test to check overall health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Neurological Exam</measure>
    <time_frame>Day 0, Day 1, Day 2 and Day 3</time_frame>
    <description>Assessment of sensory neuron and motor responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>heart's electrical activity recorded from electrodes on the body surface</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vital signs</measure>
    <time_frame>Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)</measure>
    <time_frame>Day 0, Day 2 and Day 3</time_frame>
    <description>Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Cmax after a single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Tmax after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (Vss) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Volume of distribution is defined as the volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period</measure>
    <time_frame>Day 1 hr, 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Dose-Normalized Cmax after a single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>Dose Normalized Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast(dn)) after single dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods</measure>
    <time_frame>Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48</time_frame>
    <description>AUC (0 - inf (dn)) = Dose Normalized Area under the plasma concentration versus time curve (AUC(dn)) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IV placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06818883</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06818883</intervention_name>
    <description>Treatment</description>
    <arm_group_label>PF-06818883</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female subjects of nonchildbearing potential and/or male subjects&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study&#xD;
&#xD;
          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,&#xD;
             laboratory tests, and other study procedures&#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&#xD;
&#xD;
          -  Any condition possibly affecting the placement of an intravenous drug administration&#xD;
             line.&#xD;
&#xD;
          -  A confirmed positive urine drug screen&#xD;
&#xD;
          -  History of regular alcohol consumption exceeding 7 drinks/week for females or 14&#xD;
             drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of&#xD;
             beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening&#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;
          -  Treatment with an investigational drug within 30 days (or as determined by the local&#xD;
             requirement)&#xD;
&#xD;
          -  Screening supine blood pressure &gt;140 mm Hg (systolic) or &lt;90 mm Hg (diastolic),&#xD;
             following at least 5 minutes of supine rest&#xD;
&#xD;
          -  Screening supine 12-lead ECG demonstrating QTc &gt;450 msec or a QRS interval &gt;120 msec.&#xD;
&#xD;
          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 60 days prior to dosing.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia&#xD;
&#xD;
          -  History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for&#xD;
             HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or&#xD;
             hepatitis C antibody (HCVAb).&#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;
      </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=C0601001&amp;StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Sponsor-open%2C+Placebo-controlled%2C+Single-ascending+Dose+Study+To+Evaluate+The+Safety%2C+Tolerability+And+Pharmacokinetics+Of+Pf-06818883+Following+Single+Intravenous+Administration+In+Healthy+Subjects</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>December 7, 2017</last_update_submitted>
  <last_update_submitted_qc>December 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute neuroinflammatory</keyword>
  <!-- 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/NCT03020784
org study id: C0601001
nct id: NCT03020784
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Safety, Tolerability and Pharmacokinetics of PF-06818883
allocation: Randomized
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Day 0, Day 1, Day 2, Day 3
description: An assessment of Adverse Events
measure: Change in Physical examination
time frame: Day 0, Day 1, Day 2 and Day 3
description: Safety test to check overall health
measure: Change in Neurological Exam
time frame: Day 0, Day 1, Day 2 and Day 3
description: Assessment of sensory neuron and motor responses
measure: Change in 12-lead ECG (electrocardiogram)
time frame: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
description: heart's electrical activity recorded from electrodes on the body surface
measure: Change in Vital signs
time frame: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
description: clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions
measure: Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
time frame: Day 0, Day 2 and Day 3
description: Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition
measure: Maximum Observed Plasma Concentration (Cmax) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Cmax after a single dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Tmax after single dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
measure: Plasma Decay Half-Life (t1/2) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
measure: Clearance (CL) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
measure: Volume of Distribution (Vss) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Volume of distribution is defined as the volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
measure: Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period
time frame: Day 1 hr, 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Dose-Normalized Cmax after a single dose
measure: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: Dose Normalized Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast(dn)) after single dose
measure: Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods
time frame: Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48
description: AUC (0 - inf (dn)) = Dose Normalized Area under the plasma concentration versus time curve (AUC(dn)) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
arm group label: Placebo
arm group type: Placebo Comparator
description: IV placebo
arm group label: PF-06818883
arm group type: Experimental
description: Experimental drug
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: PF-06818883
description: Treatment
arm group label: PF-06818883
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=C0601001&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Sponsor-open%2C+Placebo-controlled%2C+Single-ascending+Dose+Study+To+Evaluate+The+Safety%2C+Tolerability+And+Pharmacokinetics+Of+Pf-06818883+Following+Single+Intravenous+Administration+In+Healthy+Subjects
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor