Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methadone-Maintenance Subjects
Intervention: MOA-728 (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
To evaluate the effects of single oral doses of MOA-728 compared to a positive control in
subjects on methadone therapy.
Clinical Details
Official title: A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Primary outcome: To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion:
1. Healthy men or women, aged 18 to 65 years.
2. History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.
Exclusion:
1. History or active presence of clinically important medical disease.
2. Allergy to opioids.
Locations and Contacts
Gainesville, Florida 32608, United States
Additional Information
Starting date: July 2007
Ending date: December 2007
Last updated: January 23, 2008
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