Status:
TERMINATED
Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components
Lead Sponsor:
Bionovo
Conditions:
Healthy
Eligibility:
FEMALE
40-65 years
Phase:
PHASE1
Brief 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...
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 heal...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00453297
Start Date
October 1 2006
End Date
April 1 2007
Last Update
August 29 2008
Active Locations (1)
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1
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80012