NCT03013439

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Iron Isomaltoside	The trial is a dose escalating trial.

Timeline

• Start date: 2017-01-06
• Primary completion: 2017-06-04
• Completion: 2017-06-04
• First posted: 2017-01-06
• Last updated: 2017-12-12

Locations

1 site across 1 country: Japan