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

Pharmacosmos

Status and phase: Completed; Phase 1

Conditions: Anemia; Anemia, Iron Deficiency; Hematologic Disease; Deficiency Diseases; Iron Metabolism Disorders

Treatments: Drug: Iron Isomaltoside

Study type: Interventional

Funder types: Industry

Identifiers

NCT03013439

P-Monofer-PK-IDA-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

cohort 1 iron isomaltoside

Experimental group

Description:

treated with first dose level of iron isomaltoside

Treatment:

Drug: Iron Isomaltoside

cohort 2 iron isomaltoside

Experimental group

Description:

treated with second dose level of iron isomaltoside

Treatment:

Drug: Iron Isomaltoside

cohort 3 iron isomaltoside

Experimental group

Description:

treated with third dose level of iron isomaltoside

Treatment:

Drug: Iron Isomaltoside

cohort 4 iron isomaltoside

Experimental group

Description:

treated with fourth dose level of iron isomaltoside

Treatment:

Drug: Iron Isomaltoside