Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Methadone-maintenance Subjects

Treatments: Drug: MOA-728

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447811

3200A3-1109

Details and patient eligibility

About

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind