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Tacoma, Washington 98418


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00787007


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Tacoma, Washington 98418
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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