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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 iron isomaltoside | Experimental | treated with first dose level of iron isomaltoside |
|
| cohort 2 iron isomaltoside | Experimental | treated with second dose level of iron isomaltoside |
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| cohort 3 iron isomaltoside | Experimental | treated with third dose level of iron isomaltoside |
|
| cohort 4 iron isomaltoside | Experimental | treated with fourth dose level of iron isomaltoside |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside | Drug | The trial is a dose escalating trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of adverse events | Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma drug concentration [Cmax] | 1 week | |
| Area Under the Curve [AUC] | 1 week | |
| Time to reach one-half of the maximum drug concentration [T1/2] |
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Inclusion Criteria:
Exclusion criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ikebukuro | Tokyo | 171-0014 | Japan |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D003677 | Deficiency Diseases |
| D018798 | Anemia, Iron-Deficiency |
| D006402 | Hematologic Diseases |
| D019189 | Iron Metabolism Disorders |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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|
| 1 week |
| Time to reach maximum drug concentration [Tmax] | 1week |
| Change in concentration of hemoglobin (g/dL) | 1 week |
| Change in concentration of serum ferritin (ng/mL) | 1 week |
| Change in concentration of total iron binding capacity (μg/dL ) | 1 week |
| Change in concentrations of transferrin saturation (%) | 1 week |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
| D008659 | Metabolic Diseases |