Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
MOA-728, an investigational drug, is currently being studied for the relief of constipation associated with postoperative ileus and treatment of opioid induced constipation in patients receiving palliative care. This study will further investigate the IV formulation of MOA-728 comparing PK/PD time points for a 20-minute versus a 4-hour infusion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Double-Dummy, 2-Period Crossover Study to Characterize the PK/PD Relationship of a 20-Minute Versus a 4-hour Intravenous Infusion of MOA-728 in Subjects on Stable Methadone Maintenance|
- It is not known if the activity of MOA-728 is related to the peak concentration or the overall exposure (AUC). This study is designed to evaluate the PK and PD effect of MOA-728 administered either as a 20-minute or 4-hour infusion.
|Study Start Date:||March 2007|
|Study Completion Date:||July 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444158
|United States, Florida|
|Gainesville, Florida, United States, 32608|
|Study Director:||Jeff Cohn||Salix Pharmaceuticals|