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CompletedNCT00447811Updated Nov 25, 2019

Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

A Phase 1 interventional study of MOA-728 in Methadone-maintenance Subjects, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by Bausch Health Americas, Inc. · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Methadone-maintenance Subjects

Keywords

  • Methadone
03

In context

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double

Interventions

  • DrugMOA-728
06

What researchers measure

Primary outcomes

  1. Pharmacokinetics

Secondary outcomes

  1. Safety, tolerability, and pharmacodynamics

07

Study locations

1 site
  • Willingboro, New Jersey 08046, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00447811
Lead sponsor
Bausch Health Americas, Inc.
First posted
Mar 15, 2007
Start date
Mar 2007
Completion
May 2007
Last update
Nov 25, 2019

Study contacts

Jeff Cohn
study director · Bausch Health Americas, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Bausch Health Americas, Inc.

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