Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components
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|ClinicalTrials.gov Identifier: NCT00453297|
Recruitment Status : Terminated
First Posted : March 28, 2007
Last Update Posted : August 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: MF101||Phase 1|
Bionovo has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Study Start Date :||October 2006|
|Study Completion Date :||April 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453297
|United States, Colorado|
|University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80012|
|Principal Investigator:||Thomas Henthorn||University of Colorado, Denver|