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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Recruitment Status : Withdrawn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.

Tracking Information
First Submitted Date  ICMJE July 16, 2007
First Posted Date  ICMJE July 23, 2007
Last Update Posted Date November 29, 2019
Study Start Date  ICMJE July 2007
Estimated Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2007)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy
Official Title  ICMJE 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
Brief Summary To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Methadone-maintenance Subjects
Intervention  ICMJE Drug: MOA-728
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 26, 2019)		 0
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2007
Estimated Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00505583
Other Study ID Numbers  ICMJE 3200A3-1110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jeff Cohn, Salix Pharmaceuticals
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Bausch Health Americas, Inc.
Original Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeff Cohn Bausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date November 2019

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