Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

This study has been completed.

First Received: March 13, 2007 Last Updated: December 3, 2007 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetics

Secondary Outcome Measures:

Safety, tolerability, and pharmacodynamics

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

No publications provided

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

Keywords provided by Wyeth:

Methadone

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010