NCT00387491

Brief Summary

To assess the effect of a single oral dose of MOA-728, an investigational drug, on the oral-cecal transit time in subjects who are taking methadone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

October 11, 2006

Last Update Submit

November 21, 2019

Conditions

Adult

Outcome Measures

Primary Outcomes (1)

  • Oral-cecal transit time will be evaluated.

Interventions

MOA-728DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
1. Men or nonlactating and nonpregnant women, aged 18 to 65 years 2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

Study Officials

  • Jeff Cohn

    Bausch Health Americas, Inc.

    STUDY DIRECTOR

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

October 11, 2006

First Posted

October 13, 2006

Study Start

June 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

US(1)