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

NCT ID: NCT03013439

Last Updated: 2017-12-12

Basic Information

• 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

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Iron Isomaltoside

The trial is a dose escalating trial.

Intervention Type: DRUG

Other Intervention Names

Monofer

Eligibility 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

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

Pharmacosmos A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ikebukuro

Tokyo, , Japan

Countries

Japan

Other Identifiers

P-Monofer-PK-IDA-01

Identifier Type: -

Identifier Source: org_study_id