Dose Ranging Study in Healthy Methadone Maintenance Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387491
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : July 25, 2011
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Adult Drug: MOA-728 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : June 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone
U.S. FDA Resources

Primary Outcome Measures :
  1. Oral-cecal transit time will be evaluated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  1. Men or nonlactating and nonpregnant women, aged 18 to 65 years
  2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00387491

United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.

Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00387491     History of Changes
Other Study ID Numbers: 3200A3-102
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents