Healthy
Conditions
Keywords
healthy volunteers, pharmacokinetics
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.
Interventions
DRUGS-equol
capsule, oral, single dose
DRUGPlacebo
capsule, oral, single dose
Sponsors
Ausio Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed