Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00464802
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2007-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Placebo-Controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Comparison With the Current Formulation in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine the safety and tolerability of the new IV formulation versus the current formulation of MOA-728 focusing on the theoretical potential for infusion-related and formulation-related complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: