Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance
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: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics
of MOA-728 in subjects on stable methadone maintenance.
Clinical Details
Official title: 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
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Primary outcome: Pharmacokinetics
Secondary outcome: Safety, tolerability, and pharmacodynamics
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Willingboro, New Jersey 08046, United States
Additional Information
Starting date: March 2007
Ending date: May 2007
Last updated: December 3, 2007
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