Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

Inclusion Criteria: * Healthy male and female volunteers aged 18 to 65 years, inclusive * Female subjects must be non-pregnant and non-lactating; surgically sterile, post-menopausal or be using an acceptable non-hormonal method of birth control * Must not have used any hormonal agents or devices within 4 weeks prior to enrollment * In good health as determined by a physician * BMI between 18 and 30, inclusive * Normal clinical laboratory test results * Negative drug and alcohol toxicology screens * Negative HIV antibody and hepatitis panel screening results * For men over 44 years of age, PSA ≤ 2.0 ng/mL * For women over 44 years of age, normal mammography and pelvic ultrasound * Protein C and Protein S activity levels above the lower limit of normal * Negative for Factor V Leiden. Exclusion Criteria: * History of any chronic, subacute or acute condition of clinical significance * Total bilirubin level \>0.9, conjugated bilirubin \>0.4, or unconjugated bilirubin \>0.8 * Fasting cholesterol level \>280 mg/dL; fasting triglyceride level \>1.5 x ULN * History of thromboembolic events or estrogen-dependent benign or malignant neoplasm * Resting systolic blood pressure \>140 mm Hg or \<90 mm Hg, or diastolic blood pressure \>90 mm Hg or \<60 mm Hg * Resting pulse \>100 beats/minute or \<45 beats/minute * Abnormal 12-lead ECG or telemetry results * Subject is unwilling or unable to comply with study rules * History of sudden cardiac death in the immediate family, or a personal history of cardiac disease, treated hypertension, congestive heart failure, or unexplained syncope * History of cancer, other than basal cell carcinoma or stage 1 squamous cell carcinoma, that has not been successfully treated * Use of any prescription or over-the-counter medication within 1 week prior to Day -1 or anticipates the need for any medication during the course of the study * History or intolerance to estrogen medication * History of substance abuse, drug addiction, or alcoholism within 3 years * Inability to abstain from alcohol, caffeine, Yerba mate tea, or from grapefruit, grapefruit juice or flavonoid-rich foods from 48 hours prior to the administration of study medication and throughout the duration of the study. * History of smoking or any use of a tobacco or nicotine containing product within 6 months * Donated blood or blood products within 30 days * Mental instability or inability to be compliant with the protocol * Subject has received an investigational test substance within 60 days or anticipates receiving any investigational test substance other than S-equol during the course of this study * Subject has been previously enrolled in this study