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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013439
• Other study ID #: P-Monofer-PK-IDA-01
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2016
• Last updated: December 8, 2017
• Start date: January 6, 2017
• Est. completion date: June 4, 2017

Study information

• Verified date: January 2017
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 4, 2017
• Est. primary completion date: June 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Hematologic Disease
• Hematologic Diseases
• Iron Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• Iron Isomaltoside
The trial is a dose escalating trial.

Locations

Country	Name	City	State
Japan	Ikebukuro	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of adverse events	Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.	1 week
Secondary	Maximum plasma drug concentration [Cmax]		1 week
Secondary	Area Under the Curve [AUC]		1 week
Secondary	Time to reach one-half of the maximum drug concentration [T1/2]		1 week
Secondary	Time to reach maximum drug concentration [Tmax]		1week
Secondary	Change in concentration of hemoglobin (g/dL)		1 week
Secondary	Change in concentration of serum ferritin (ng/mL)		1 week
Secondary	Change in concentration of total iron binding capacity (µg/dL )		1 week
Secondary	Change in concentrations of transferrin saturation (%)		1 week