HealthyPhase 1NCT00998920
Multi-Dose 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 to evaluate the safety and tolerability of escalating multiple doses of S-equol administered twice daily (BID) for 14 days to healthy male and female subjects and to describe the pharmacokinetic profile of S-equol. 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
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2009
- 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
- subject is capable of reading, understanding and complying with the protocol and has signed the informed consent document prior to undergoing any study related procedures;
- subject is male or female and is 18 (at the time of consent) to 65 years of age, inclusive (subjects are required to meet the latter age limits by the time of first dosing);
- subject, if female, must be non-lactating, and have a negative serum pregnancy test result during the Pretreatment Period. Women of child-bearing potential must be willing to stay in the clinic from Day -10 until the end of the dosing period to confirm non-pregnant status.
- subject, if female, must be surgically sterile (must be documented); post-menopausal (defined as at least 2 years without menses with screening FSH in expected range) or must be using acceptable methods of non-hormonal contraception (Mirena is acceptable). For this study, estrogen-containing contraceptives are not acceptable. Postmenopausal women must not have had any vaginal spotting or bleeding in the past year;
- subject has not had any hormonal agents or devices within 4 weeks prior to enrollment (Mirena is acceptable. n.b. Mirena can cause irregular menstrual cycles; however, this would not be exclusionary for the purposes of this protocol);
- subject, if a woman of child-bearing potential, must have had two consecutive normal menstrual cycles immediately prior to enrollment;
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- subject must be in good health as determined by a physician (i.e., via medical history at the Pretreatment Screening Period, physical examination and screening laboratory results at the Pretreatment Screening and Baseline Periods);
- subject must weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 30, inclusive, at Pretreatment Screening Period;
- subject must have had normal clinical laboratory test results or, if abnormal, the clinical laboratory tests are not clinically significant in the Investigator's opinion, during the Pretreatment Periods;
- subject must have negative drug and alcohol toxicology screens during the Pretreatment Screening Period; and
- subject must have negative HIV antibody and hepatitis panel screening results during the Pretreatment Screening Period.
- For men over 44 years of age, Prostate Specific Antigen (PSA) is less than or equal to 2.0 ng/mL;
- For women over 44 years of age, mammography (within 3 months prior to Day 1) and pelvic ultrasound, with results showing no significant abnormality in the opinion of the Investigator, and specifically no suggestion of breast or endometrial neoplasm;
- subject must have Protein C and Protein S activity levels above the lower limit of normal;
- subject must have a negative test for Factor V Leiden.
Who cannot join
- subject has a history of any chronic condition of clinical significance, in the Investigator's opinion, that would preclude participation in the study (e.g. any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality);
- subject has a total bilirubin level greater than 0.9 mg/dL, a conjugated bilirubin greater than 0.4 mg/dL or an unconjugated bilirubin greater than 0.8 mg/dL at Screening; Fasting cholesterol level at screening is greater than 280 mg/dL; Fasting triglyceride level at screening is greater than 1.5 x the upper limit of normal;
- subject has any history of thromboembolic events or estrogen-dependent benign or malignant neoplasm;
- subject has resting systolic blood pressure >140 mm Hg or <90 mm Hg, or diastolic blood pressure >90 mm Hg or <60 mm Hg during the Pretreatment Screening Period;
- subject has a resting pulse >100 beats/minute or <45 beats/minute during the Pretreatment Screening Period;
- subject does not have a normal 12-lead electrocardiogram (ECG) during the Pretreatment Screening Period, or, if abnormal, the ECG is clinically significant in the opinion of the Investigator;
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- subject is unwilling to comply with study rules, including attempting to void at specified times (prior to ECG time points) or maintain quiet, undistracted, awake, motionless supine posture during specified time points or exhibits anxious, excitable, hostile, or emotionally reactive affect;
- subject cannot tolerate a controlled, quiet study conduct environment, including avoidance during specified time points of music, TV, movies, games and activities that may cause excitement, emotional tension or arousal;
- subject has a history of sudden cardiac death in the immediate family, or a personal history of cardiac disease, treated hypertension, congestive heart failure, or unexplained syncope;
- subject has a previous history of cancer, other than basal cell carcinoma or stage 1 squamous cell carcinoma that has not been successfully treated;
- subject has taken any prescription or over-the-counter medication within 1 week prior to the Pretreatment Baseline Period (Day -1), or anticipates the need for any medication during the course of the study;
- subject has a history of intolerance to estrogen medication;
- subject has a history of substance abuse, drug addiction, or alcoholism within 3 years prior to the Pretreatment Baseline Period. (According to the DSM IV, alcohol abuse is defined as average consumption of more than 4 alcoholic drinks per day.);
- subject anticipates an inability to abstain from alcohol, caffeine or 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. Coca tea and mate de coca are not allowed within 1 week prior to Screening;
- subject has a history of smoking or any use of a tobacco product within 6 months prior to the Pretreatment Baseline Period;
- subject has donated blood or blood products within 30 days prior to the Pretreatment Baseline Period;
- subject is mentally unstable or is incapable of being compliant with the protocol;
- subject has received an investigational test substance within 60 days prior to the administration of investigational test article, or anticipates receiving any investigational test substance other than S-equol during the course of this study; or
- 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, Rising Multiple Dose Study of S-Equol in Normal Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of S-equol administered twice daily (BID) for 14 days to healthy male and female subjects and to describe the pharmacokinetic profile of S-equol.
Read the detailed description
The study is a randomized, double-blind, placebo-controlled trial of doses escalated by cohort. Volunteers will be randomized to receive active study drug or placebo twice daily (BID) for 14 days. This study will be staggered in timing with the single rising dose study (Protocol AUS-CT01) being conducted concurrently, such that the lowest dose cohort of this multiple rising dose study may begin after evaluation of safety and pharmacokinetic data from the first 8 subjects randomized to the 10 mg dose cohort of the single rising dose study and safety data from the 8 Subjects randomized in the 20 mg dose cohort of that study.
- Conditions
- Healthy
- Being tested
- S-equol, Placebo
- Keywords
- Healthy volunteers
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
oral, BID, 14 days
PlaceboDrug
oral, BID, 14 days
| Study group | Role | What they receive |
|---|---|---|
| 10mg BID | Experimental | S-equol capsule, oral, single dose Receives: Drug: S-equol |
| 20 mg BID | Experimental | Not described Receives: Drug: S-equol |
| 40mg BID | Experimental | Not described Receives: Drug: S-equol |
| 80 mg BID | Experimental | Not described Receives: Drug: S-equol |
| 160 mg BID | Experimental | Not described Receives: Drug: S-equol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Measured: 14 days
Secondary outcomes (1)
Total and free S-equol concentrations
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionApr 2009
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ausio Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bianchi, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998920
- Sponsor's protocol ID
- AUS-CT02
- Status last verified
- Jul 2012
- First submitted
- 12 Oct 2009
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Rising Multiple Dose Study of S-Equol in Normal Volunteers
- ClinicalTrials.gov ID
- NCT00998920
- Acronym / sponsor ID
- AUS-CT02
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ausio Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Oct 2009 (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 to evaluate the safety and tolerability of escalating multiple doses of S-equol administered twice daily (BID) for 14 days to healthy male and female subjects and to describe the pharmacokinetic profile of S-equol.
Detailed description
The study is a randomized, double-blind, placebo-controlled trial of doses escalated by cohort. Volunteers will be randomized to receive active study drug or placebo twice daily (BID) for 14 days. This study will be staggered in timing with the single rising dose study (Protocol AUS-CT01) being conducted concurrently, such that the lowest dose cohort of this multiple rising dose study may begin after evaluation of safety and pharmacokinetic data from the first 8 subjects randomized to the 10 mg dose cohort of the single rising dose study and safety data from the 8 Subjects randomized in the 20 mg dose cohort of that study.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 10mg BID | Experimental | Drug: S-equolS-equol capsule, oral, single dose |
| 20 mg BID | Experimental | Drug: S-equol |
| 40mg BID | Experimental | Drug: S-equol |
| 80 mg BID | Experimental | Drug: S-equol |
| 160 mg BID | Experimental | Drug: S-equol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- subject is capable of reading, understanding and complying with the protocol and has signed the informed consent document prior to undergoing any study related procedures;
- subject is male or female and is 18 (at the time of consent) to 65 years of age, inclusive (subjects are required to meet the latter age limits by the time of first dosing);
- subject, if female, must be non-lactating, and have a negative serum pregnancy test result during the Pretreatment Period. Women of child-bearing potential must be willing to stay in the clinic from Day -10 until the end of the dosing period to confirm non-pregnant status.
- subject, if female, must be surgically sterile (must be documented); post-menopausal (defined as at least 2 years without menses with screening FSH in expected range) or must be using acceptable methods of non-hormonal contraception (Mirena is acceptable). For this study, estrogen-containing contraceptives are not acceptable. Postmenopausal women must not have had any vaginal spotting or bleeding in the past year;
- subject has not had any hormonal agents or devices within 4 weeks prior to enrollment (Mirena is acceptable. n.b. Mirena can cause irregular menstrual cycles; however, this would not be exclusionary for the purposes of this protocol);
Key exclusion criteria (19 listed)
- subject has a history of any chronic condition of clinical significance, in the Investigator's opinion, that would preclude participation in the study (e.g. any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality);
- subject has a total bilirubin level greater than 0.9 mg/dL, a conjugated bilirubin greater than 0.4 mg/dL or an unconjugated bilirubin greater than 0.8 mg/dL at Screening; Fasting cholesterol level at screening is greater than 280 mg/dL; Fasting triglyceride level at screening is greater than 1.5 x the upper limit of normal;
- subject has any history of thromboembolic events or estrogen-dependent benign or malignant neoplasm;
- subject has resting systolic blood pressure >140 mm Hg or <90 mm Hg, or diastolic blood pressure >90 mm Hg or <60 mm Hg during the Pretreatment Screening Period;
- subject has a resting pulse >100 beats/minute or <45 beats/minute during the Pretreatment Screening Period;
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-131oral, BID, 14 days | Drug | 10mg BID, 160 mg BID, 20 mg BID, 40mg BID, 80 mg BID |
| Placebooral, BID, 14 days | Drug | Placebo |
Primary outcome
Treatment-emergent adverse events
Time frame: 14 days
1 secondary outcome
Total and free S-equol concentrations
Time frame: 14 days
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 12 Jul 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.
Elizabeth Bianchi, MD principal investigator
Syneos Health
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 15 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 12 Jul 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?
Treatment-emergent adverse events (time frame: 14 days). 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 12 Jul 2012.