Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT01088932
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2010-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Dose Safety Study of SRX246 Capsules in Healthy Volunteers
Sponsor:
Azevan Pharmaceuticals
Organization:
Study Overview
Official Title:
Phase I, Double-Blind, Placebo-Controlled, Ascending, Multiple-Dose, Safety, Tolerability and Pharmacokinetic Study of SRX246 Capsules in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2010-07
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:
AVN007
Brief Summary:
This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.
Detailed Description:
This study is intended to evaluate the safety, tolerability and pharmacokinetic profile of multiple oral doses of SRX246 in healthy adult volunteers.
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?: