<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/NCT02998099</url>
  </required_header>
  <id_info>
    <org_study_id>B5201004</org_study_id>
    <nct_id>NCT02998099</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.</brief_title>
  <official_title>A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP SINGLE-DOSE STUDY TO ESTIMATE THE EFFECT OF AGE ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF INTRAVENOUS RIVIPANSEL (PF-06460031)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlycoMimetics Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlycoMimetics Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of&#xD;
      IV rivipansel.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to time of the last quantifiable concentration as data permit.</measure>
    <time_frame>Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of IV rivipansel</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance (CL)</measure>
    <time_frame>Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration</measure>
    <time_frame>Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration</measure>
    <time_frame>Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean elimination half-life</measure>
    <time_frame>Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at steady state</measure>
    <time_frame>Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination</measure>
    <time_frame>Baseline up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of adverse events</measure>
    <time_frame>Baseline up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of 12-lead electrocardiogram</measure>
    <time_frame>Baseline up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vital signs</measure>
    <time_frame>Baseline up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of laboratory tests</measure>
    <time_frame>Baseline up to 72 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Banked Biospecimen</measure>
    <time_frame>Day 0</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Aged 18-45 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of IV rivipansel over 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aged 65 and older</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of IV rivipansel over 20 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivipansel</intervention_name>
    <description>A single dose of IV rivipansel over 20 minutes.</description>
    <arm_group_label>Aged 18-45 years</arm_group_label>
    <arm_group_label>Aged 65 and older</arm_group_label>
    <other_name>GMI-1070</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female subjects of non-childbearing potential or healthy male subjects who are&#xD;
             between the ages of 18-45 years or 65 years of age or older.&#xD;
&#xD;
          -  Body mass index (BMI) of 17.5 to 40 kg/m2&#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 drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at the time of dosing).&#xD;
&#xD;
          -  Pregnant females; breastfeeding female subjects; male subjects with partners currently&#xD;
             pregnant&#xD;
&#xD;
          -  Treatment with another investigational drug within 30 days or 5 half-lives preceding&#xD;
             the dose of study medication&#xD;
&#xD;
          -  Blood donation within 60 days prior to dosing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteers</keyword>
  <keyword>Rivipansel</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02998099
org study id: B5201004
nct id: NCT02998099
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of
      IV rivipansel.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to time of the last quantifiable concentration as data permit.
time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of IV rivipansel
measure: Clearance (CL)
time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.
measure: Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration
time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.
measure: Maximum plasma concentration
time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.
measure: Mean elimination half-life
time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.
measure: Volume of distribution at steady state
time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.
measure: Physical examination
time frame: Baseline up to 72 hours
measure: Assessment of adverse events
time frame: Baseline up to 28 days
measure: Assessment of 12-lead electrocardiogram
time frame: Baseline up to 72 hours
measure: Assessment of vital signs
time frame: Baseline up to 72 hours
measure: Assessment of laboratory tests
time frame: Baseline up to 72 hours
measure: Banked Biospecimen
time frame: Day 0
arm group label: Aged 18-45 years
arm group type: Experimental
description: A single dose of IV rivipansel over 20 minutes.
arm group label: Aged 65 and older
arm group type: Experimental
description: A single dose of IV rivipansel over 20 minutes.
intervention type: Drug
intervention name: Rivipansel
description: A single dose of IV rivipansel over 20 minutes.
arm group label: Aged 18-45 years
arm group label: Aged 65 and older
other name: GMI-1070
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No