Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance
Phase 1
Completed
- Conditions
- Methadone-maintenance Subjects
- Registration Number
- NCT00447811
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Pharmacokinetics
- Secondary Outcome Measures
Name Time Method Safety, tolerability, and pharmacodynamics