Anemia, Deficiency Diseases, Anemia, Iron Deficiency, Hematologic Disease, Iron Metabolism Disorders
Conditions
Brief summary
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
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.
Interventions
The trial is a dose escalating trial.
Sponsors
Pharmacosmos A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of adverse events | 1 week | Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness. |
Secondary
| Measure | Time frame |
|---|---|
| Change in concentration of serum ferritin (ng/mL) | 1 week |
| Change in concentration of total iron binding capacity (μg/dL ) | 1 week |
| Maximum plasma drug concentration [Cmax] | 1 week |
| Change in concentration of hemoglobin (g/dL) | 1 week |
| Time to reach one-half of the maximum drug concentration [T1/2] | 1 week |
| Time to reach maximum drug concentration [Tmax] | 1week |
| Change in concentrations of transferrin saturation (%) | 1 week |
| Area Under the Curve [AUC] | 1 week |
Countries
Japan
Outcome results
None listed