NCT00998920

Multi-Dose Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

Randomized, Double-Blind, Rising Multiple Dose Study of S-Equol in Normal Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Ausio Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	S-equol	oral, BID, 14 days
DRUG	Placebo	oral, BID, 14 days

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-10-21
• Last updated: 2012-07-12

Locations

1 site across 1 country: United States