Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00998920
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2009-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Dose Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
Sponsor:
Ausio Pharmaceuticals, LLC
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Rising Multiple Dose Study of S-Equol in Normal Volunteers
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of S-equol administered twice daily (BID) for 14 days to healthy male and female subjects and to describe the pharmacokinetic profile of S-equol.
Detailed Description:
The study is a randomized, double-blind, placebo-controlled trial of doses escalated by cohort. Volunteers will be randomized to receive active study drug or placebo twice daily (BID) for 14 days. This study will be staggered in timing with the single rising dose study (Protocol AUS-CT01) being conducted concurrently, such that the lowest dose cohort of this multiple rising dose study may begin after evaluation of safety and pharmacokinetic data from the first 8 subjects randomized to the 10 mg dose cohort of the single rising dose study and safety data from the 8 Subjects randomized in the 20 mg dose cohort of that study.
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?: