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Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00505583
Enrollment
0
Registered
2007-07-23
Start date
2007-07-31
Completion date
2007-12-31
Last updated
2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methadone-maintenance Subjects

Brief summary

To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

Interventions

Sponsors

Bausch Health Americas, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: 1. Healthy men or women, aged 18 to 65 years. 2. History of methadone treatment for at least 1 month, at a dose \>=30 and \<=140 mg/day. Exclusion: 1. History or active presence of clinically important medical disease. 2. Allergy to opioids.

Design outcomes

Primary

MeasureTime frame
To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026