Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

This study has been completed.

Sponsor:

Information provided by:

Salix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00447811

First received: March 13, 2007

Last updated: July 22, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

July 22, 2011

Start Date ^ICMJE

March 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics

Original Primary Outcome Measures ^ICMJE

Phamacokinetics

Change History

Complete list of historical versions of study NCT00447811 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety, tolerability, and pharmacodynamics

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

Official Title ^ICMJE

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

Brief Summary

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic

Condition ^ICMJE

Methadone-maintenance Subjects

Intervention ^ICMJE

Drug: MOA-728

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

May 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00447811

Other Study ID Numbers ^ICMJE

3200A3-1109

Has Data Monitoring Committee

Not Provided

Responsible Party

Jeff Cohn, Salix Pharmaceuticals

Study Sponsor ^ICMJE

Salix Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jeff Cohn

Salix Pharmaceuticals

Information Provided By

Salix Pharmaceuticals

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top