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

NCT ID: NCT03013439

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-06

Study Completion Date

2017-06-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Anemia Deficiency Diseases Anemia, Iron Deficiency Hematologic Disease Iron Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cohort 1 iron isomaltoside

treated with first dose level of iron isomaltoside

Group Type EXPERIMENTAL

Iron Isomaltoside

Intervention Type DRUG

The trial is a dose escalating trial.

cohort 2 iron isomaltoside

treated with second dose level of iron isomaltoside

Group Type EXPERIMENTAL

Iron Isomaltoside

Intervention Type DRUG

The trial is a dose escalating trial.

cohort 3 iron isomaltoside

treated with third dose level of iron isomaltoside

Group Type EXPERIMENTAL

Iron Isomaltoside

Intervention Type DRUG

The trial is a dose escalating trial.

cohort 4 iron isomaltoside

treated with fourth dose level of iron isomaltoside

Group Type EXPERIMENTAL

Iron Isomaltoside

Intervention Type DRUG

The trial is a dose escalating trial.

Interventions

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Iron Isomaltoside

The trial is a dose escalating trial.

Intervention Type DRUG

Other Intervention Names

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Monofer

Eligibility Criteria

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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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacosmos A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ikebukuro

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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P-Monofer-PK-IDA-01

Identifier Type: -

Identifier Source: org_study_id