Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

NCT00787007 | Completed Phase 1 DMC

• 1 other identifier: AUS-CT01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

healthy volunteers; pharmacokinetics

Outcome Measures

Primary Outcomes (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.

  Continuous

Secondary Outcomes (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.

  Variable

Study Arms (7)

1

EXPERIMENTAL

10 mg

Drug: S-equol

2

EXPERIMENTAL

20 mg, fasted and fed

Drug: S-equol

3

EXPERIMENTAL

40 mg

Drug: S-equol

4

EXPERIMENTAL

80 mg

Drug: S-equol

5

EXPERIMENTAL

160 mg

Drug: S-equol

6

EXPERIMENTAL

320 mg

Drug: S-equol

7

PLACEBO COMPARATOR

placebo capsule

Drug: Placebo

Interventions

S-equol DRUG

capsule, oral, single dose

Also known as: AUS-131

1; 2; 3; 4; 5; 6

Placebo DRUG

capsule, oral, single dose

7

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ausio Pharmaceuticals, LLC: lead

Study Sites (1)

Charles River

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

Equol

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

US (1)