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Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 7, 2007
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
March 5, 2007
March 7, 2007
July 26, 2011
March 2007
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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.
Same as current
Complete list of historical versions of study NCT00444158 on ClinicalTrials.gov Archive Site
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Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
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
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.
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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Drug: MOA-728
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2007
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Inclusion Criteria:

  • Generally healthy men and nonlactating, nonpregnant women age 18 to 65 years with BMI of 18.0 to 35.0 kg/m2
  • Must have been receiving methadone treatment of greater than or equal to 30 mg/day for at least one month and a positive drug screen for methadone
  • High probability for compliance with and completion of the study

Exclusion Criteria:

  • Significant cardiovascular, hepatic, renal , respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Presence or history of any disorder that may prevent the successful completion of the study. Any surgical or medical condition that my interfere with the distribution, metabolism or excretion of the test article.
  • Acute disease state, family history of long QT syndrome and/or sudden cardiac death, allergy to opioids or drugs. Use of any investigational or prescription drugs within 30 days, any OTC drugs including herbal supplements within 14 days and drugs required to maintain regulation of bowel movements 48 hours before study day 1.
  • History of alcoholism within 1 month before study day 1, admitted alcohol abuse, or consumption of more than 2 standard units of alcohol per day.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Jeff Cohn, Salix Pharmaceuticals
Valeant Pharmaceuticals International, Inc.
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Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP