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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:


Further study details as provided by Wyeth:

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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387491

Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
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 November 25, 2009