Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT00532467
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2007-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Dose Safety Study of SRX251 Capsules in Healthy Volunteers
Sponsor:
Azevan Pharmaceuticals
Organization:
Study Overview
Official Title:
Phase I, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic Study of SRX251 Capsules in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2008-03
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 is the second study to evaluate SRX251 in healthy volunteers and it represents the first multiple dose study. The primary objective of this study is to evaluate the safety and tolerability of escalating multiple oral doses of SRX251 capsules for 5 days in healthy adult volunteers. Levels of the drug in blood plasma will also be determined.
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?: