Clinical Trials Logo
  1. Home
  2. Methadone-maintenance Subjects
  3. NCT00447811
  4. Details
NCT00447811 Clinical Trial

Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

Methadone-maintenance Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00447811
Other study ID # 3200A3-1109
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2007
Est. completion date May 2007

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

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

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 Pharmacokinetics
Secondary Safety, tolerability, and pharmacodynamics
See also
  Status Clinical Trial Phase
Withdrawn NCT00505583 - Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy Phase 1