Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components
Bionovo has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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.|
- 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
- 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.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453297
|United States, Colorado|
|University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80012|
|Principal Investigator:||Thomas Henthorn||University of Colorado, Denver|