HealthyPhase 1NCT00787007
Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
A Phase 1 study testing S-equol in people with Healthy, run by Ausio Pharmaceuticals, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- S-equol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Single Rising Dose Study of S-equol in Normal Volunteers
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- S-equol, Placebo
- Keywords
- healthy volunteers, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-equolDrug
Also called AUS-131
capsule, oral, single dose
PlaceboDrug
capsule, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 10 mg Receives: Drug: S-equol |
| 2 | Experimental | 20 mg, fasted and fed Receives: Drug: S-equol |
| 3 | Experimental | 40 mg Receives: Drug: S-equol |
| 4 | Experimental | 80 mg Receives: Drug: S-equol |
| 5 | Experimental | 160 mg Receives: Drug: S-equol |
| 6 | Experimental | 320 mg Receives: Drug: S-equol |
| 7 | Placebo comparator | placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ausio Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787007
- Sponsor's protocol ID
- AUS-CT01
- Status last verified
- Jan 2012
- First submitted
- 6 Nov 2008
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Single Rising Dose Study of S-equol in Normal Volunteers
- ClinicalTrials.gov ID
- NCT00787007
- Acronym / sponsor ID
- AUS-CT01
- Conditions
- Healthy
- Keywords
- healthy volunteers, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ausio Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-equol10 mg |
| 2 | Experimental | Drug: S-equol20 mg, fasted and fed |
| 3 | Experimental | Drug: S-equol40 mg |
| 4 | Experimental | Drug: S-equol80 mg |
| 5 | Experimental | Drug: S-equol160 mg |
| 6 | Experimental | Drug: S-equol320 mg |
| 7 | Placebo comparator | Drug: Placeboplacebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-equolAlso: AUS-131capsule, oral, single dose | Drug | 1, 2, 3, 4, 5, 6 |
| Placebocapsule, oral, single dose | Drug | 7 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-equol in people with Healthy, run by Ausio Pharmaceuticals, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.