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

Phase 1

Completed

• Conditions: Anemia, Iron Deficiency; Anemia; Deficiency Diseases; Hematologic Disease; Iron Metabolism Disorders
• Interventions: Drug: Iron Isomaltoside

• Registration Number: NCT03013439
• Lead Sponsor: Pharmacosmos A/S

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.

Study Timeline

• Study First Submitted: 2016-12-22
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-05
• Study Start: 2017-01-06
• Study First Posted: 2017-01-06
• Primary Completion: 2017-06-04
• Study Completion: 2017-06-04
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 2 iron isomaltoside	Iron Isomaltoside	treated with second dose level of iron isomaltoside
cohort 3 iron isomaltoside	Iron Isomaltoside	treated with third dose level of iron isomaltoside
cohort 4 iron isomaltoside	Iron Isomaltoside	treated with fourth dose level of iron isomaltoside
cohort 1 iron isomaltoside	Iron Isomaltoside	treated with first dose level of iron isomaltoside

Primary Outcome Measures

Name	Time	Method
Proportion of adverse events	1 week	Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.

Secondary Outcome Measures

Name	Time	Method
Time to reach maximum drug concentration [Tmax]	1week
Change in concentration of hemoglobin (g/dL)	1 week
Change in concentration of serum ferritin (ng/mL)	1 week
Maximum plasma drug concentration [Cmax]	1 week
Area Under the Curve [AUC]	1 week
Time to reach one-half of the maximum drug concentration [T1/2]	1 week
Change in concentration of total iron binding capacity (μg/dL )	1 week
Change in concentrations of transferrin saturation (%)	1 week

Trial Locations

Locations (1)

Ikebukuro; 🇯🇵 Tokyo, Japan