Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

This study has been withdrawn prior to enrollment.
Information provided by:
Valeant Pharmaceuticals International, Inc. Identifier:
First received: July 16, 2007
Last updated: July 22, 2011
Last verified: July 2011
To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Condition Intervention Phase
Methadone-maintenance Subjects
Drug: MOA-728
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

Study Start Date: July 2007
Estimated Study Completion Date: December 2007
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes


  1. Healthy men or women, aged 18 to 65 years.
  2. History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.


  1. History or active presence of clinically important medical disease.
  2. Allergy to opioids.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00505583

United States, Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00505583     History of Changes
Other Study ID Numbers: 3200A3-1110
Study First Received: July 16, 2007
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration processed this record on November 25, 2015