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Trial record 14 of 36 for:    pharmacosmos

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

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ClinicalTrials.gov Identifier: NCT03013439
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

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

Condition or disease Intervention/treatment Phase
Anemia Deficiency Diseases Anemia, Iron Deficiency Hematologic Disease Iron Metabolism Disorders 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 6, 2017
Actual Primary Completion Date : June 4, 2017
Actual Study Completion Date : June 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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 Name: 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 Name: 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 Name: 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 Name: Monofer




Primary Outcome Measures :
  1. Proportion of adverse events [ Time Frame: 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] [ Time Frame: 1 week ]
  2. Area Under the Curve [AUC] [ Time Frame: 1 week ]
  3. Time to reach one-half of the maximum drug concentration [T1/2] [ Time Frame: 1 week ]
  4. Time to reach maximum drug concentration [Tmax] [ Time Frame: 1week ]
  5. Change in concentration of hemoglobin (g/dL) [ Time Frame: 1 week ]
  6. Change in concentration of serum ferritin (ng/mL) [ Time Frame: 1 week ]
  7. Change in concentration of total iron binding capacity (μg/dL ) [ Time Frame: 1 week ]
  8. Change in concentrations of transferrin saturation (%) [ Time Frame: 1 week ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013439


Locations
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Japan
Ikebukuro
Tokyo, Japan, 171-0014
Sponsors and Collaborators
Pharmacosmos A/S

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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03013439     History of Changes
Other Study ID Numbers: P-Monofer-PK-IDA-01
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Metabolic Diseases
Hematologic Diseases
Deficiency Diseases
Iron Metabolism Disorders
Anemia, Hypochromic
Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs