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

Healthy Clinical Trial

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.

Status Terminated

Clinical 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. 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT00453297
• Study type: Interventional
• Source: Bionovo
• Status: Terminated
• Phase: Phase 1
• Start date: October 2006
• Completion date: April 2007