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

Exclusion Criteria

• •subject has a history of any chronic condition of clinical significance, in the Investigator's opinion, that would preclude participation in the study (e.g. any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality);
• •subject has a total bilirubin level greater than 0.9 mg/dL, a conjugated bilirubin greater than 0.4 mg/dL or an unconjugated bilirubin greater than 0.8 mg/dL at Screening; Fasting cholesterol level at screening is greater than 280 mg/dL; Fasting triglyceride level at screening is greater than 1.5 x the upper limit of normal;
• •subject has any history of thromboembolic events or estrogen-dependent benign or malignant neoplasm;
• •subject has resting systolic blood pressure \>140 mm Hg or \<90 mm Hg, or diastolic blood pressure \>90 mm Hg or \<60 mm Hg during the Pretreatment Screening Period;
• •subject has a resting pulse \>100 beats/minute or \<45 beats/minute during the Pretreatment Screening Period;
• •subject does not have a normal 12-lead electrocardiogram (ECG) during the Pretreatment Screening Period, or, if abnormal, the ECG is clinically significant in the opinion of the Investigator;
• •subject is unwilling to comply with study rules, including attempting to void at specified times (prior to ECG time points) or maintain quiet, undistracted, awake, motionless supine posture during specified time points or exhibits anxious, excitable, hostile, or emotionally reactive affect;
• •subject cannot tolerate a controlled, quiet study conduct environment, including avoidance during specified time points of music, TV, movies, games and activities that may cause excitement, emotional tension or arousal;
• •subject has a history of sudden cardiac death in the immediate family, or a personal history of cardiac disease, treated hypertension, congestive heart failure, or unexplained syncope;
• •subject has a previous history of cancer, other than basal cell carcinoma or stage 1 squamous cell carcinoma that has not been successfully treated;
• •subject has taken any prescription or over-the-counter medication within 1 week prior to the Pretreatment Baseline Period (Day -1), or anticipates the need for any medication during the course of the study;
• •subject has a history of intolerance to estrogen medication;
• •subject has a history of substance abuse, drug addiction, or alcoholism within 3 years prior to the Pretreatment Baseline Period. (According to the DSM IV, alcohol abuse is defined as average consumption of more than 4 alcoholic drinks per day.);
• •subject anticipates an inability to abstain from alcohol, caffeine or 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. Coca tea and mate de coca are not allowed within 1 week prior to Screening;
• •subject has a history of smoking or any use of a tobacco product within 6 months prior to the Pretreatment Baseline Period;
• •subject has donated blood or blood products within 30 days prior to the Pretreatment Baseline Period;
• •subject is mentally unstable or is incapable of being compliant with the protocol;
• •subject has received an investigational test substance within 60 days prior to the administration of investigational test article, or anticipates receiving any investigational test substance other than S-equol during the course of this study; or
• •subject has been previously enrolled in this study.