NCT00505583

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

July 16, 2007

Last Update Submit

November 26, 2019

Conditions

Methadone-maintenance Subjects

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

MOA-728DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men or women, aged 18 to 65 years.
  • History of methadone treatment for at least 1 month, at a dose \>=30 and \<=140 mg/day.

You may not qualify if:

  • History or active presence of clinically important medical disease.
  • Allergy to opioids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Gainesville, Florida, 32608, United States

Location

Study Officials

  • Jeff Cohn

    Bausch Health Americas, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 23, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations

US(1)