NCT00787007

Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

Randomized, Double-Blind, Single Rising Dose Study of S-equol in Normal Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ausio Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is 1) to test the safety of S-equol in healthy volunteers and 2) to see how quickly S-equol enters the bloodstream, is distributed in the body, and broken down and removed, when taken with food or without food.

Detailed description

The study is a double blind, randomized, placebo-controlled, dose-escalation study of the safety and tolerability of single doses of S-equol up to 320 mg in healthy male and female adult subjects. Approximately 8 qualified volunteers will be selected at each dose level and randomly assigned to receive S-equol or placebo, in the fasted state. For the 20 mg dose group, subjects will complete two treatment periods, one in the fasted state, and one in the fed state. A safety review of study results for each dose group will occur when Day 8 follow-up visit safety data are available, and prior to enrollment/dosing of the next subsequent dose group. Given favorable safety review of a dose group's experience, the subsequent dose group will be enrolled/dosed at least 10 days after the previous group's dosing. Pharmacokinetic evaluations consist of determination of plasma and urine concentrations of free and total conjugated S-equol at various time points. Safety evaluations include physical examination,vital signs, ECG, serum chemistry, hematology, and urinalysis, 12-lead telemetry, and assessment of clinical signs and symptoms.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	S-equol	capsule, oral, single dose
DRUG	Placebo	capsule, oral, single dose

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-11-07
• Last updated: 2012-01-20

Locations

1 site across 1 country: United States