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

NCT03013439 | Completed Phase 1

• 1 other identifier: P-Monofer-PK-IDA-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of adverse events

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

  1 week

Secondary Outcomes (8)

• 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

• Time to reach maximum drug concentration [Tmax]

  1week

• Change in concentration of hemoglobin (g/dL)

  1 week

Study Arms (4)

cohort 1 iron isomaltoside

EXPERIMENTAL

treated with first dose level of iron isomaltoside

Drug: Iron Isomaltoside

cohort 2 iron isomaltoside

EXPERIMENTAL

treated with second dose level of iron isomaltoside

Drug: Iron Isomaltoside

cohort 3 iron isomaltoside

EXPERIMENTAL

treated with third dose level of iron isomaltoside

Drug: Iron Isomaltoside

cohort 4 iron isomaltoside

EXPERIMENTAL

treated with fourth dose level of iron isomaltoside

Drug: Iron Isomaltoside

Interventions

Iron Isomaltoside DRUG

The trial is a dose escalating trial.

Also known as: Monofer

cohort 1 iron isomaltoside; cohort 2 iron isomaltoside; cohort 3 iron isomaltoside; cohort 4 iron isomaltoside

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Ikebukuro

Tokyo, 171-0014, Japan

Location

MeSH Terms

Conditions

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

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Iron Deficiencies; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 6, 2017
• Study Start: January 6, 2017
• Primary Completion: June 4, 2017
• Study Completion: June 4, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)