Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00787007

Run by

Ausio Pharmaceuticals, LLC

People needed

60

Starts

2008-09-01

Expected to finish

2008-12-01

Last updated by the study team

2012-01-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Charles River — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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