Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components

Stopped early · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00453297

Run by

Bionovo

People needed

32

Starts

2006-10-01

Expected to finish

2007-04-01

Last updated by the study team

2008-08-29

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado Health Sciences Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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