Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
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

Drug Information available for: Methadone Methadone hydrochloride

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment
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

Further study details as provided by Wyeth:

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

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3200A3-1109
Study First Received:	March 13, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00447811
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Methadone

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Methadone

Guaifenesin
Phenylephrine
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009