Dose Ranging Study in Healthy Methadone Maintenance Subjects

This study has been completed.

First Received on October 11, 2006. Last Updated on July 22, 2011 History of Changes

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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 Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

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

Salix Pharmaceuticals

Investigators

Study Director:

Jeff Cohn

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00387491 History of Changes
Other Study ID Numbers:	3200A3-102
Study First Received:	October 11, 2006
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

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