Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360425
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2006-08-02
Brief Title:
A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
Sponsor:
AMAG Pharmaceuticals Inc
Organization:
AMAG Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Active- and Placebo-Controlled Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will define the effects of ferumoxytol on electrocardiogram ECG data as well as evaluate pharmacokinetics
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None