Status:
COMPLETED
Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
Lead Sponsor:
Ausio Pharmaceuticals, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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, w...
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. App...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00787007
Start Date
September 1 2008
End Date
December 1 2008
Last Update
January 20 2012
Active Locations (1)
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1
Charles River
Tacoma, Washington, United States, 98418