HealthyPhase 1NCT00453297
Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components
A Phase 1 study testing MF101 in people with Healthy, run by Bionovo at 1 site in United States.
Trial summary
This Phase I trial in healthy, post-menopausal women is designed as a double-blind, placebo-controlled, randomized, ascending single-dose safety trial. MF101 will be administered as a single oral dose to a total of 32 enrolled subjects between the ages of 40-65 years. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MF101
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Apr 2007
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal females, in good health and between 40 and 65 years of age.
- Normal body mass index equal or greater than 18 but not greater than 36
- Postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 30 mlU/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or hysterectomy with FSH levels > 30 mlU/ml.
- Ability to comprehend and a willingness to sign an informed consent form.
- Ability and willingness to understand and follow study procedures.
- Clinical laboratory evaluations within the reference range for the testing laboratory, unless regarded not clinically significant by the Principle Investigator.
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- Must have had mammogram within the last 9 months.
- Negative urine test for selected drugs of abuse at screening and after check-in at the study unit.
- Negative hepatitis panel (including HBsAg and anti-HCV), and HIV antibody screens.
- No chronic medications being taken.
- Must have a primary care physician.
Who cannot join
- History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, hepatic, gall bladder, renal, urological, or psychiatric disorders.
- Dyslipidemia
- History of abnormal renal function, uncontrolled hypertension, or malignancies.
- History of breast, uterine or ovarian cancer or melanoma.
- History of brain aneurism or ischemic events.
- Febrile disease
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- Autoimmune disorders such as lupus erythematosis, multiple sclerosis or rheumatoid arthritis.
- Severe vasomotor symptoms defined as > 7/day or >50/week.
- Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
- Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
- Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
- Unexplained abnormal uterine bleeding within six months of enrollment.
- Pregnancy or lactating.
- History of deep vein thrombosis or pulmonary embolism requiring anticoagulation.
- History of hypersensitivity or allergies to any drug compound, including the constituents of MF101 unless approved by the Principle Investigator.
- History or presence of a clinically significant abnormal ECG (QTcB > 450msec at screening or variation in QTcB > 30msec at screening).
- Likely to need medication during the study including contraceptives.
- History of alcoholism or drug addiction within 1 year prior to study entry (i.e., prior to check-in on Day-1).
- Use of any tobacco products (including cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum) within 6 months prior to study entry.
- Receipt of any investigational drug within 60 days prior to study entry.
- Use of prescription medications known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs.
- Use of raloxifene, tamoxifen or aromatase inhibitors within three months of enrollment.
- Use of any other prescription medication or any alcohol-containing products/medications within 14 days prior to study entry.
- Use of over-the-counter, non-prescription preparations, within 7 days prior to study entry.
- Use of any caffeine-containing products/medications within 72 hours prior to study entry.
- Donation of blood within 6 weeks prior to study entry or of plasma within 2 weeks prior to screening.
- Receipt of blood products within 2 months prior to study entry.
- Any other condition or prior therapy which, in the opinion of the Investigator, would make the subject unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Aurora, Colorado, 80012
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Oral, Dose Escalation Phase 1 Study to Evaluate the Safety and Tolerance of MF 101 as Well as the Pharmacokinetics of Its Key Active Components in Healthy Post-Menopausal Women.
This Phase I trial in healthy, post-menopausal women is designed as a double-blind, placebo-controlled, randomized, ascending single-dose safety trial. MF101 will be administered as a single oral dose to a total of 32 enrolled subjects between the ages of 40-65 years. Eight subjects will be assigned to each of four cohorts. Within each cohort, six subjects will be randomized to receive MF101 and two subjects will receive placebo. MF101 doses will be incrementally escalated until the stopping criteria are reached. If stopping criteria are reached before the fourth cohort receives dosing, the next cohort may receive a dose between the dose that was administered to the cohort exhibiting symptoms of MF101 toxicity and the next lower dose group.
Read the detailed description
The primary goal of this study is to identify the highest safe oral dose of MF101 that is well tolerated in humans.
Secondary goals include: characterizing clinical symptoms of MF101 toxicity in healthy subjects and evaluating the dose-dependent pharmacokinetics of key MF101 active components after a single oral dose.
- Conditions
- Healthy
- Being tested
- MF101
- Keywords
- Bionovo, MF101, Herbs, The primary goal of this study is to identify the highest safe oral dose of MF101 that is well tolerated in humans.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF101Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the highest oral dose of MF101 that is safe and tolerated in humans.
Number and type of adverse events
Clinical laboratory including: Chemistry, hematology, blood coagulation and urinalysis
Physical exam and vital signs
Secondary outcomes (3)
Characterize MF101 toxicity and associated clinical symptoms in healthy subjects.
Establish cardiac safety (QTcB).
Study the dose dependent pharmacokinetics of MF101's key active components after oral administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startOct 2006
- Study completionApr 2007
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Henthorn, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453297
- Sponsor's protocol ID
- MF-101-003
- Status last verified
- Aug 2008
- First submitted
- 26 Mar 2007
- Last updated
- 29 Aug 2008
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Oral, Dose Escalation Phase 1 Study to Evaluate the Safety and Tolerance of MF 101 as Well as the Pharmacokinetics of Its Key Active Components in Healthy Post-Menopausal Women.
- ClinicalTrials.gov ID
- NCT00453297
- Acronym / sponsor ID
- MF-101-003
- Conditions
- Healthy
- Keywords
- Bionovo, MF101, Herbs, The primary goal of this study is to identify the highest safe oral dose of MF101 that is well tolerated in humans.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- BionovoIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Mar 2007 (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.
This Phase I trial in healthy, post-menopausal women is designed as a double-blind, placebo-controlled, randomized, ascending single-dose safety trial. MF101 will be administered as a single oral dose to a total of 32 enrolled subjects between the ages of 40-65 years. Eight subjects will be assigned to each of four cohorts. Within each cohort, six subjects will be randomized to receive MF101 and two subjects will receive placebo. MF101 doses will be incrementally escalated until the stopping criteria are reached. If stopping criteria are reached before the fourth cohort receives dosing, the next cohort may receive a dose between the dose that was administered to the cohort exhibiting symptoms of MF101 toxicity and the next lower dose group.
Detailed description
The primary goal of this study is to identify the highest safe oral dose of MF101 that is well tolerated in humans.
Secondary goals include: characterizing clinical symptoms of MF101 toxicity in healthy subjects and evaluating the dose-dependent pharmacokinetics of key MF101 active components after a single oral dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Post-menopausal females, in good health and between 40 and 65 years of age.
- Normal body mass index equal or greater than 18 but not greater than 36
- Postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 30 mlU/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or hysterectomy with FSH levels > 30 mlU/ml.
- Ability to comprehend and a willingness to sign an informed consent form.
- Ability and willingness to understand and follow study procedures.
Key exclusion criteria (28 listed)
- History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, hepatic, gall bladder, renal, urological, or psychiatric disorders.
- Dyslipidemia
- History of abnormal renal function, uncontrolled hypertension, or malignancies.
- History of breast, uterine or ovarian cancer or melanoma.
- History of brain aneurism or ischemic events.
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 |
|---|---|---|
| MF101 | Drug | – |
Primary outcome
Identify the highest oral dose of MF101 that is safe and tolerated in humans.
Number and type of adverse events
Clinical laboratory including: Chemistry, hematology, blood coagulation and urinalysis
Physical exam and vital signs
3 secondary outcomes
Characterize MF101 toxicity and associated clinical symptoms in healthy subjects.
Establish cardiac safety (QTcB).
Study the dose dependent pharmacokinetics of MF101's key active components after oral administration.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2008.
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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.
Thomas Henthorn principal investigator
University of Colorado, Denver
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 MF101 in people with Healthy, run by Bionovo 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 11 inclusion and 28 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: stopped early, as of the sponsor's last update on 29 Aug 2008. 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. 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 was stopped early. Results are not available in the source record.
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?
Identify the highest oral dose of MF101 that is safe and tolerated in humans.. The study lists 4 primary outcomes in all. 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 29 Aug 2008.