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Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00787007
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: S-equol Drug: Placebo 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Double-Blind, Single Rising Dose Study of S-equol in Normal Volunteers
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
10 mg
Drug: S-equol
capsule, oral, single dose
Other Name: AUS-131

Experimental: 2
20 mg, fasted and fed
Drug: S-equol
capsule, oral, single dose
Other Name: AUS-131

Experimental: 3
40 mg
Drug: S-equol
capsule, oral, single dose
Other Name: AUS-131

Experimental: 4
80 mg
Drug: S-equol
capsule, oral, single dose
Other Name: AUS-131

Experimental: 5
160 mg
Drug: S-equol
capsule, oral, single dose
Other Name: AUS-131

Experimental: 6
320 mg
Drug: S-equol
capsule, oral, single dose
Other Name: AUS-131

Placebo Comparator: 7
placebo capsule
Drug: Placebo
capsule, oral, single dose




Primary Outcome Measures :
  1. 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. [ Time Frame: Continuous ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Variable ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787007


Locations
United States, Washington
Charles River
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Ausio Pharmaceuticals, LLC

Responsible Party: Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00787007     History of Changes
Other Study ID Numbers: AUS-CT01
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Ausio Pharmaceuticals, LLC:
healthy volunteers
pharmacokinetics

Additional relevant MeSH terms:
Equol
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs