A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women

NCT00360425 | Completed Phase 1

• 1 other identifier: 62,745-9
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as evaluate pharmacokinetics

Conditions

Anemia

Keywords

anemia; intravenous iron; pharmacokinetics; QTc

Outcome Measures

Primary Outcomes (3)

• To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on the QTcI interval compared to placebo and to a single dose of 400 mg moxifloxacin.

• To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on QT, QTcB, QTcF and heart rate (HR).

• To assess the pharmacokinetics of two doses of 510 mg ferumoxytol administered within 24 hours.

Secondary Outcomes (2)

• To describe the relationship between exposure to ferumoxytol and ECG parameters (QTcI, QT, QTcB, QTcF and HR).

• To assess the safety and tolerability of a supratherapeutic dose of ferumoxytol (2 doses of 510 mg ferumoxytol administered within 24 hours).

Interventions

ferumoxytol DRUG

moxifloxacin DRUG

placebo DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and females, 18 - 45 years of age, inclusive.
• Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial.
• Subjects must give written informed consent and sign Health Insurance Portability and Accountability Act (HIPAA) guidelines to be in the study.
• Hemoglobin ≥ 10 g/dL and ≤ 16 g/dL for males and ≥ 10 g/dL and ≤ 14 g/dL for females.
• Transferrin saturation (TSAT) ≤ 35%
• Serum ferritin ≤ 100 ng/mL.
• Subjects must have a body mass index (BMI) between 19.0 and 30.0 kg/m2
• Subjects must have no clinically significant abnormal findings on the physical examination.

You may not qualify if:

• Subjects currently participating in a clinical trial with another investigational new drug or device or who have received an investigational new drug or device within 30 days or 5 half-lives (whichever is longer) prior to randomization into this study.
• Subjects who have been on parenteral or oral iron therapy within 30 days prior to dosing.
• Subjects with active infections requiring ongoing treatment.
• Subjects with a positive human immunodeficiency virus type 1 or type 2 (HIV-1 or HIV-2) antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test.
• Abnormal liver function tests.
• Subjects who have had malignancy (except for non-melanoma of the skin), unless the subject has received curative treatment and has been disease free for \> 2 years.
• Subjects with a history of risk factors for Torsades de pointes (TdP) \[e.g., family history (parents or siblings) of long QT syndrome\], history of fainting, unexplained loss of consciousness or convulsions.
• Clinically relevant abnormality on screening ECG
• Subjects who have a sustained supine systolic blood pressure (SBP) \> 150 mmHg or \< 90 mmHg or a diastolic blood pressure (DBP) \< 45 or \> 95 mmHg at screening or baseline.
• Subjects who have a pulse rate at rest of \< 45 bpm or \> 100 bpm.
• Subjects who are unable to stop smoking during the study (Day -1 to Day 7). Subjects who smoke 10 or more cigarettes a day.
• Excessive consumption (\> 6 units per day) of food or beverages with xanthine or caffeine bases (e.g., tea, coffee, chocolate, cola; 1 unit of caffeine is contained in 6 oz of coffee, 4 oz of energy drink, 24 oz of cola, 12 oz of tea and 3 oz chocolate).
• History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men.
• Subjects with any allergies to iron products, moxifloxacin or multiple drug (two or more) allergies as reported by the subject or as determined by the investigator.
• Subjects who have taken medications \[with the exception of Tylenol (acetaminophen) ≤ 2g/day, multi-vitamin that does not contain iron, hormonal contraception for females and hormone replacement therapy (HRT) in the case of menopausal subjects\] within 7 days or 5 half-lives (whichever is longer) prior to randomization into this study.

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (1)

Unknown Facility

Baltimore, Maryland, 21225, United States

Location

Related Publications (1)

• Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.

  PMID: 16088081 BACKGROUND

Related Links

• National Kidney Foundation
• National Anemia Action Council
• Kidney Disease Outcomes Quality Initiative

MeSH Terms

Conditions

Anemia

Interventions

Ferrosoferric Oxide; Moxifloxacin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 4, 2006
• Study Start: May 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 4, 2022

Record last verified: 2022-04

Locations

US (1)