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

Primary Purpose

Anemia, Deficiency Diseases, Anemia, Iron Deficiency

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Iron Isomaltoside

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Japanese man or woman ≥ 20 years, < 65 years of age
Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men
Serum ferritin < 25 ng/mL
TIBC ≥ 360 μg/dL
Body weight ≥ 50 kg
Willingness to participate and signing the informed consent form

Exclusion criteria include:

Anemia caused by conditions other than iron deficiency
Cancer
IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
Erythropoiesis stimulating agent (ESA) treatment prior to screening
Imminent expectation of blood transfusion on part of treating physician
Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)
Known hypersensitivity reaction to iv iron preparations
Decompensated liver cirrhosis or active hepatitis
Active acute or chronic infections
Pregnant or nursing women.
Planned elective surgery during the trial

Sites / Locations

Ikebukuro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

cohort 1 iron isomaltoside

cohort 2 iron isomaltoside

cohort 3 iron isomaltoside

cohort 4 iron isomaltoside

Arm Description

treated with first dose level of iron isomaltoside

treated with second dose level of iron isomaltoside

treated with third dose level of iron isomaltoside

treated with fourth dose level of iron isomaltoside

Outcomes

Primary Outcome Measures

Proportion of adverse events

Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.

Secondary Outcome Measures

Maximum plasma drug concentration [Cmax]

Area Under the Curve [AUC]

Time to reach one-half of the maximum drug concentration [T1/2]

Time to reach maximum drug concentration [Tmax]

Change in concentration of hemoglobin (g/dL)

Change in concentration of serum ferritin (ng/mL)

Change in concentration of total iron binding capacity (μg/dL )

Change in concentrations of transferrin saturation (%)

Full Information

NCT ID

NCT03013439

First Posted

December 22, 2016

Last Updated

December 8, 2017

Sponsor

Pharmacosmos A/S

1. Study Identification

Unique Protocol Identification Number

NCT03013439

Brief Title

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

Official Title

Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

January 6, 2017 (Actual)

Primary Completion Date

June 4, 2017 (Actual)

Study Completion Date

June 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cohort 1 iron isomaltoside

Arm Type

Experimental

Arm Description

treated with first dose level of iron isomaltoside

Arm Title

cohort 2 iron isomaltoside

Arm Type

Experimental

Arm Description

treated with second dose level of iron isomaltoside

Arm Title

cohort 3 iron isomaltoside

Arm Type

Experimental

Arm Description

treated with third dose level of iron isomaltoside

Arm Title

cohort 4 iron isomaltoside

Arm Type

Experimental

Arm Description

treated with fourth dose level of iron isomaltoside

Intervention Type

Drug

Intervention Name(s)

Iron Isomaltoside

Other Intervention Name(s)

Monofer

Intervention Description

The trial is a dose escalating trial.

Primary Outcome Measure Information:

Title

Proportion of adverse events

Description

Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Maximum plasma drug concentration [Cmax]

Time Frame

1 week

Title

Area Under the Curve [AUC]

Time Frame

1 week

Title

Time to reach one-half of the maximum drug concentration [T1/2]

Time Frame

1 week

Title

Time to reach maximum drug concentration [Tmax]

Time Frame

1week

Title

Change in concentration of hemoglobin (g/dL)

Time Frame

1 week

Title

Change in concentration of serum ferritin (ng/mL)

Time Frame

1 week

Title

Change in concentration of total iron binding capacity (μg/dL )

Time Frame

1 week

Title

Change in concentrations of transferrin saturation (%)

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Japanese man or woman ≥ 20 years, < 65 years of age Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men Serum ferritin < 25 ng/mL TIBC ≥ 360 μg/dL Body weight ≥ 50 kg Willingness to participate and signing the informed consent form Exclusion criteria include: Anemia caused by conditions other than iron deficiency Cancer IV or oral iron treatment, or blood transfusion 4 weeks prior to screening Erythropoiesis stimulating agent (ESA) treatment prior to screening Imminent expectation of blood transfusion on part of treating physician Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis) Known hypersensitivity reaction to iv iron preparations Decompensated liver cirrhosis or active hepatitis Active acute or chronic infections Pregnant or nursing women. Planned elective surgery during the trial

Facility Information:

Facility Name

Ikebukuro

City

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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