Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
- Registration Number
- NCT00787007
- Lead Sponsor
- Ausio Pharmaceuticals, LLC
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7 Placebo placebo capsule 2 S-equol 20 mg, fasted and fed 1 S-equol 10 mg 3 S-equol 40 mg 4 S-equol 80 mg 5 S-equol 160 mg 6 S-equol 320 mg
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of ascending, single oral doses of S-equol, administered in fasted and fed states, in healthy male and female volunteers. Continuous
- Secondary Outcome Measures
Name Time Method To evaluate the single dose pK profile of S-equol in the fed and fasted state. To compare the pK profiles of younger and older and male and female volunteers. Variable
Trial Locations
- Locations (1)
Charles River
🇺🇸Tacoma, Washington, United States