Dose Ranging Study in Healthy Methadone Maintenance Subjects

This study has been completed.

First Received: October 11, 2006 Last Updated: August 6, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00387491

Purpose

To assess the effect of a single oral dose of MOA-728, an investigational drug, on the oral-cecal transit time in subjects who are taking methadone.

Condition	Intervention	Phase
Adult	Drug: MOA-728	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomized, Double-blind, 4-period Crossover, Dose-ranging Study to Determine the Effects on the Oral-cecal Transit Time of Single Doses of MOA-728 and the Safety and Tolerability of Multiple Doses of MOA-728 in Stable Methadone Maintenance Subjects

Resource links provided by NLM:

Drug Information available for: Methadone

Further study details as provided by Wyeth:

Primary Outcome Measures:

Estimated Enrollment:	16
Study Start Date:	June 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Men or nonlactating and nonpregnant women, aged 18 to 65 years
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387491

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3200A3-102
Study First Received:	October 11, 2006
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00387491 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 08, 2010