Dose Ranging Study in Healthy Methadone Maintenance Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

October 11, 2006

Last Updated Date

August 6, 2009

Start Date ^ICMJE

June 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Oral-cecal transit time will be evaluated.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00387491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dose Ranging Study in Healthy Methadone Maintenance Subjects

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Adult

Intervention ^ICMJE

Drug: MOA-728

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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 ID ^ICMJE

NCT00387491

Responsible Party

Study ID Numbers ^ICMJE

3200A3-102

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

August 2009

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