Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

This study has been completed.

First Received on March 13, 2007. Last Updated on July 22, 2011 History of Changes

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00447811

Purpose

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Two Ascending Single Doses Crossover, Placebo Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MOA-728 Administered Orally to Subjects on Stable Methadone Maintenance

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

Secondary Outcome Measures:

Study Start Date:	March 2007
Study Completion Date:	May 2007

Eligibility

Criteria

Inclusion Criteria:

History of methadone treatment for at least 1 month before day -1 at a dose of ≥ 30 mg/day, and a positive drug test result for methadone.
Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria:

Allergy to opioids (eg, codeine, morphine, or oxymorphone) or opioid antagonists (eg, naloxone or naltrexone).
Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447811

Locations

United States, New Jersey

Willingboro, New Jersey, United States, 08046

Sponsors and Collaborators

Salix Pharmaceuticals

Investigators

Study Director:

Jeff Cohn

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00447811 History of Changes
Other Study ID Numbers:	3200A3-1109
Study First Received:	March 13, 2007
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

Methadone

Additional relevant MeSH terms:

Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012