MedTrace Logo

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

NCT00453297 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2008-08-29

No results posted yet for this study

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

Interventions

DRUG

MF101

Sponsors & Collaborators

  • Bionovo

    lead INDUSTRY

Principal Investigators

  • Thomas Henthorn · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453297 on ClinicalTrials.gov