Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

Methadone-maintenance Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00505583
• Other study ID #: 3200A3-1110
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Methadone-maintenance Subjects

Intervention

Drug:
• MOA-728

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.