Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

NCT ID: NCT00447811

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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Conditions

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Methadone-maintenance Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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MOA-728

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Salix Pharmaceuticals

Principal Investigators

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Jeff Cohn

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

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Willingboro, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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3200A3-1109

Identifier Type: -

Identifier Source: org_study_id

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