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

NCT00453297 | Terminated Phase 1

• 1 other identifier: MF-101-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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.

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.

Outcome Measures

Primary Outcomes (4)

• 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.

Interventions

MF101 DRUG

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bionovo: lead

Study Sites (1)

University of Colorado Health Sciences Center

Aurora, Colorado, 80012, United States

Location

Study Officials

• Thomas Henthorn

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 28, 2007
• Study Start: October 1, 2006
• Study Completion: April 1, 2007
• Last Updated: August 29, 2008

Record last verified: 2008-08

Locations

US (1)