<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/NCT03013439</url>
  </required_header>
  <id_info>
    <org_study_id>P-Monofer-PK-IDA-01</org_study_id>
    <nct_id>NCT03013439</nct_id>
  </id_info>
  <brief_title>Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)</brief_title>
  <official_title>Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmacosmos A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pharmacosmos A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as&#xD;
      inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone&#xD;
      bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on&#xD;
      the subjects, and treatment of these subjects includes controlling the bleeding and&#xD;
      replenishing lost iron.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">June 4, 2017</completion_date>
  <primary_completion_date type="Actual">June 4, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of adverse events</measure>
    <time_frame>1 week</time_frame>
    <description>Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma drug concentration [Cmax]</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve [AUC]</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach one-half of the maximum drug concentration [T1/2]</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum drug concentration [Tmax]</measure>
    <time_frame>1week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of hemoglobin (g/dL)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of serum ferritin (ng/mL)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of total iron binding capacity (μg/dL )</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in concentrations of transferrin saturation (%)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Anemia</condition>
  <condition>Deficiency Diseases</condition>
  <condition>Anemia, Iron Deficiency</condition>
  <condition>Hematologic Disease</condition>
  <condition>Iron Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>cohort 1 iron isomaltoside</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treated with first dose level of iron isomaltoside</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cohort 2 iron isomaltoside</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treated with second dose level of iron isomaltoside</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cohort 3 iron isomaltoside</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treated with third dose level of iron isomaltoside</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cohort 4 iron isomaltoside</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treated with fourth dose level of iron isomaltoside</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Isomaltoside</intervention_name>
    <description>The trial is a dose escalating trial.</description>
    <arm_group_label>cohort 1 iron isomaltoside</arm_group_label>
    <arm_group_label>cohort 2 iron isomaltoside</arm_group_label>
    <arm_group_label>cohort 3 iron isomaltoside</arm_group_label>
    <arm_group_label>cohort 4 iron isomaltoside</arm_group_label>
    <other_name>Monofer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Japanese man or woman ≥ 20 years, &lt; 65 years of age&#xD;
&#xD;
          2. Hb of ≥ 9.0 g/dL, &lt; 12.0 g/dL for women and &lt; 13.0 g/dL for men&#xD;
&#xD;
          3. Serum ferritin &lt; 25 ng/mL&#xD;
&#xD;
          4. TIBC ≥ 360 μg/dL&#xD;
&#xD;
          5. Body weight ≥ 50 kg&#xD;
&#xD;
          6. Willingness to participate and signing the informed consent form&#xD;
&#xD;
        Exclusion criteria include:&#xD;
&#xD;
          1. Anemia caused by conditions other than iron deficiency&#xD;
&#xD;
          2. Cancer&#xD;
&#xD;
          3. IV or oral iron treatment, or blood transfusion 4 weeks prior to screening&#xD;
&#xD;
          4. Erythropoiesis stimulating agent (ESA) treatment prior to screening&#xD;
&#xD;
          5. Imminent expectation of blood transfusion on part of treating physician&#xD;
&#xD;
          6. Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)&#xD;
&#xD;
          7. Known hypersensitivity reaction to iv iron preparations&#xD;
&#xD;
          8. Decompensated liver cirrhosis or active hepatitis&#xD;
&#xD;
          9. Active acute or chronic infections&#xD;
&#xD;
         10. Pregnant or nursing women.&#xD;
&#xD;
         11. Planned elective surgery during the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ikebukuro</name>
      <address>
        <city>Tokyo</city>
        <zip>171-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>December 8, 2017</last_update_submitted>
  <last_update_submitted_qc>December 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</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>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Deficiency Diseases</mesh_term>
    <mesh_term>Iron Metabolism Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron isomaltoside 1000</mesh_term>
  </intervention_browse>
  <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/NCT03013439
org study id: P-Monofer-PK-IDA-01
nct id: NCT03013439
lead sponsor: 
has dmc: No
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as
      inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone
      bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on
      the subjects, and treatment of these subjects includes controlling the bleeding and
      replenishing lost iron.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of adverse events
time frame: 1 week
description: Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.
measure: Maximum plasma drug concentration [Cmax]
time frame: 1 week
measure: Area Under the Curve [AUC]
time frame: 1 week
measure: Time to reach one-half of the maximum drug concentration [T1/2]
time frame: 1 week
measure: Time to reach maximum drug concentration [Tmax]
time frame: 1week
measure: Change in concentration of hemoglobin (g/dL)
time frame: 1 week
measure: Change in concentration of serum ferritin (ng/mL)
time frame: 1 week
measure: Change in concentration of total iron binding capacity (μg/dL )
time frame: 1 week
measure: Change in concentrations of transferrin saturation (%)
time frame: 1 week
arm group label: cohort 1 iron isomaltoside
arm group type: Experimental
description: treated with first dose level of iron isomaltoside
arm group label: cohort 2 iron isomaltoside
arm group type: Experimental
description: treated with second dose level of iron isomaltoside
arm group label: cohort 3 iron isomaltoside
arm group type: Experimental
description: treated with third dose level of iron isomaltoside
arm group label: cohort 4 iron isomaltoside
arm group type: Experimental
description: treated with fourth dose level of iron isomaltoside
intervention type: Drug
intervention name: Iron Isomaltoside
description: The trial is a dose escalating trial.
arm group label: cohort 1 iron isomaltoside
arm group label: cohort 2 iron isomaltoside
arm group label: cohort 3 iron isomaltoside
arm group label: cohort 4 iron isomaltoside
other name: Monofer
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Hematologic Diseases
mesh term: Iron Deficiencies
mesh term: Metabolic Diseases
mesh term: Deficiency Diseases
mesh term: Iron Metabolism Disorders
mesh term: Iron isomaltoside 1000
sharing ipd: No