A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
A Phase 1 Active- and Placebo-Controlled Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
Sponsor: AMAG Pharmaceuticals, Inc.
Listed as NCT00360425, this PHASE1 trial focuses on Anemia and remains completed. Sponsored by AMAG Pharmaceuticals, Inc., it has been updated 7 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This trial will be conducted in order to provide an evaluation of the potential of ferumoxytol to cause cardiac arrhythmia in accordance with the International Conference on Harmonization (ICH) E14 guidance. The purpose of this trial is to define the effects of ferumoxytol on electrocardiogram (ECG) data. Pharmacokinetics will also be evaluated at multiple time points as specified. Subject safety will be monitored throughout the study.
This trial will be conducted in order to provide an evaluation of the potential of ferumoxytol to cause cardiac arrhythmia in accordance with the International Conference on Harmonization (ICH) E14 guidance. The purpose of this trial is to define the effects of ferumoxytol on electrocardiogram (ECG) data. Pharmacokinetics will also be evaluated at multiple time points as specified. Subject safety will be monitored throughout the study.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
May 2022 — Jul 2024 [monthly]
Completed PHASE1
-
Jan 2021 — May 2022 [monthly]
Completed PHASE1
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE1
First recorded
May 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- AMAG Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .