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Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

Sponsor
Pharmacosmos A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03013439
Collaborator
(none)
24
Enrollment
1
Location
4
Arms
4.9
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

Condition or Disease Intervention/Treatment Phase
  • Drug: Iron Isomaltoside
 Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 6, 2017
Actual Primary Completion Date :
Jun 4, 2017
Actual Study Completion Date :
Jun 4, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: cohort 1 iron isomaltoside

treated with first dose level of iron isomaltoside

Drug: Iron Isomaltoside
The trial is a dose escalating trial.
Other Names:
  • Monofer

    		•
    Experimental: cohort 2 iron isomaltoside

    treated with second dose level of iron isomaltoside

    Drug: Iron Isomaltoside
    The trial is a dose escalating trial.
    Other Names:
  • Monofer

    		•
    Experimental: cohort 3 iron isomaltoside

    treated with third dose level of iron isomaltoside

    Drug: Iron Isomaltoside
    The trial is a dose escalating trial.
    Other Names:
  • Monofer

    		•
    Experimental: cohort 4 iron isomaltoside

    treated with fourth dose level of iron isomaltoside

    Drug: Iron Isomaltoside
    The trial is a dose escalating trial.
    Other Names:
  • Monofer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of adverse events [1 week]

      Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.

    Secondary Outcome Measures

    1. Maximum plasma drug concentration [Cmax] [1 week]

    2. Area Under the Curve [AUC] [1 week]

    3. Time to reach one-half of the maximum drug concentration [T1/2] [1 week]

    4. Time to reach maximum drug concentration [Tmax] [1week]

    5. Change in concentration of hemoglobin (g/dL) [1 week]

    6. Change in concentration of serum ferritin (ng/mL) [1 week]

    7. Change in concentration of total iron binding capacity (μg/dL ) [1 week]

    8. Change in concentrations of transferrin saturation (%) [1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Japanese man or woman ≥ 20 years, < 65 years of age

    2. Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men

    3. Serum ferritin < 25 ng/mL

    4. TIBC ≥ 360 μg/dL

    5. Body weight ≥ 50 kg

    6. Willingness to participate and signing the informed consent form

    Exclusion criteria include:

    1. Anemia caused by conditions other than iron deficiency

    2. Cancer

    3. IV or oral iron treatment, or blood transfusion 4 weeks prior to screening

    4. Erythropoiesis stimulating agent (ESA) treatment prior to screening

    5. Imminent expectation of blood transfusion on part of treating physician

    6. Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)

    7. Known hypersensitivity reaction to iv iron preparations

    8. Decompensated liver cirrhosis or active hepatitis

    9. Active acute or chronic infections

    10. Pregnant or nursing women.

    11. Planned elective surgery during the trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ikebukuro Tokyo Japan 171-0014

    Sponsors and Collaborators

    • Pharmacosmos A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pharmacosmos A/S
    ClinicalTrials.gov Identifier:
    NCT03013439
    Other Study ID Numbers:
    • P-Monofer-PK-IDA-01
    First Posted:
    Jan 6, 2017
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Anemia
    Anemia, Iron-Deficiency
    Hematologic Diseases
    Metabolic Diseases
    Deficiency Diseases
    Iron Metabolism Disorders
    Iron isomaltoside 1000

    Study Results

    No Results Posted as of Dec 12, 2017