Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00505583
First received: July 16, 2007
Last updated: July 22, 2011
Last verified: July 2011
  Purpose
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

Resource links provided by NLM:


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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505583

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

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on December 08, 2016