Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00447811
Collaborator
(none)
1
2
Study Details
Study Description
Brief Summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Diagnostic
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 Start Date
:
Mar 1, 2007
Actual Study Completion Date
:
May 1, 2007
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics []
Secondary Outcome Measures
- Safety, tolerability, and pharmacodynamics []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Willingboro | New Jersey | United States | 08046 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00447811
Other Study ID Numbers:
- 3200A3-1109
First Posted:
Mar 15, 2007
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019
Keywords provided by ,
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