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Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

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.
 
ClinicalTrials.gov Identifier: NCT00505583
Recruitment Status : Withdrawn
First Posted : July 23, 2007
Last Update Posted : November 29, 2019
Sponsor:
Information provided by:
Bausch Health Americas, Inc.

Study Description
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Brief Summary:
To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Condition or disease Intervention/treatment Phase
Methadone-maintenance Subjects Drug: MOA-728 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : July 2007
Estimated Primary Completion Date : December 2007
Estimated Study Completion Date : December 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  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.

Exclusion:

  1. History or active presence of clinically important medical disease.
  2. Allergy to opioids.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00505583


Locations
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United States, Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Jeff Cohn Bausch Health Americas, Inc.
More Information
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Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00505583    
Other Study ID Numbers: 3200A3-1110
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019