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Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00787007
First received: November 6, 2008
Last updated: January 19, 2012
Last verified: January 2012
  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.


Condition Intervention Phase
Healthy
Drug: S-equol
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Double-Blind, Single Rising Dose Study of S-equol in Normal Volunteers

Further study details as provided by Ausio Pharmaceuticals, LLC:

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. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Variable ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787007

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

No publications provided

Responsible Party: Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00787007     History of Changes
Other Study ID Numbers: AUS-CT01
Study First Received: November 6, 2008
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ausio Pharmaceuticals, LLC:
healthy volunteers
pharmacokinetics

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

ClinicalTrials.gov processed this record on November 20, 2014