Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 5:32 AM
Study NCT ID:
NCT01290133
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2011-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV)
Sponsor:
Accenture
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Placebo-Controlled, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of the Captisol™ Formulation of Vestipitant (GW597599) in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2011-10
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:
The purpose of this study is to describe the safety and tolerability and pharmacokinetics of a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin (Captisol™) based, formulation in Healthy Adult Subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: