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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Pharmacosmos A/S

Current Primary Outcome: Proportion of adverse events [ Time Frame: 1 week ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Pharmacosmos A/S

Dates:
Date Received: December 22, 2016
Date Started: January 6, 2017
Date Completion: September 2017
Last Updated: February 2, 2017
Last Verified: January 2017