Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 10 mg |
Drug: S-equol
capsule, oral, single dose
Other Names:
|
| Experimental: 2 20 mg, fasted and fed |
Drug: S-equol
capsule, oral, single dose
Other Names:
|
| Experimental: 3 40 mg |
Drug: S-equol
capsule, oral, single dose
Other Names:
|
| Experimental: 4 80 mg |
Drug: S-equol
capsule, oral, single dose
Other Names:
|
| Experimental: 5 160 mg |
Drug: S-equol
capsule, oral, single dose
Other Names:
|
| Experimental: 6 320 mg |
Drug: S-equol
capsule, oral, single dose
Other Names:
|
| Placebo Comparator: 7 placebo capsule |
Drug: Placebo
capsule, oral, single dose
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charles River | Tacoma | Washington | United States | 98418 |
Sponsors and Collaborators
- Ausio Pharmaceuticals, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AUS-CT01