Back to resultsDouble-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
Primary Purpose
Constipation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MOA-728
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring opioids, chronic pain
Eligibility Criteria
Inclusion Criteria:
- Generally healthy men and nonlactating, nonpregnant women age 18 to 65 years with BMI of 18.0 to 35.0 kg/m2
- Must have been receiving methadone treatment of greater than or equal to 30 mg/day for at least one month and a positive drug screen for methadone
- High probability for compliance with and completion of the study
Exclusion Criteria:
- Significant cardiovascular, hepatic, renal , respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Presence or history of any disorder that may prevent the successful completion of the study. Any surgical or medical condition that my interfere with the distribution, metabolism or excretion of the test article.
- Acute disease state, family history of long QT syndrome and/or sudden cardiac death, allergy to opioids or drugs. Use of any investigational or prescription drugs within 30 days, any OTC drugs including herbal supplements within 14 days and drugs required to maintain regulation of bowel movements 48 hours before study day 1.
- History of alcoholism within 1 month before study day 1, admitted alcohol abuse, or consumption of more than 2 standard units of alcohol per day.
Sites / Locations
Outcomes
Primary Outcome Measures
It is not known if the activity of MOA-728 is related to the peak concentration or the overall exposure (AUC). This study is designed to evaluate the PK and PD effect of MOA-728 administered either as a 20-minute or 4-hour infusion.
Secondary Outcome Measures
Full Information
NCT ID
NCT00444158
First Posted
March 5, 2007
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00444158
Brief Title
Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
Official Title
A Randomized, Double-Blind, Double-Dummy, 2-Period Crossover Study to Characterize the PK/PD Relationship of a 20-Minute Versus a 4-hour Intravenous Infusion of MOA-728 in Subjects on Stable Methadone Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
5. Study Description
Brief Summary
MOA-728, an investigational drug, is currently being studied for the relief of constipation associated with postoperative ileus and treatment of opioid induced constipation in patients receiving palliative care. This study will further investigate the IV formulation of MOA-728 comparing PK/PD time points for a 20-minute versus a 4-hour infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
opioids, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MOA-728
Primary Outcome Measure Information:
Title
It is not known if the activity of MOA-728 is related to the peak concentration or the overall exposure (AUC). This study is designed to evaluate the PK and PD effect of MOA-728 administered either as a 20-minute or 4-hour infusion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Generally healthy men and nonlactating, nonpregnant women age 18 to 65 years with BMI of 18.0 to 35.0 kg/m2
Must have been receiving methadone treatment of greater than or equal to 30 mg/day for at least one month and a positive drug screen for methadone
High probability for compliance with and completion of the study
Exclusion Criteria:
Significant cardiovascular, hepatic, renal , respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Presence or history of any disorder that may prevent the successful completion of the study. Any surgical or medical condition that my interfere with the distribution, metabolism or excretion of the test article.
Acute disease state, family history of long QT syndrome and/or sudden cardiac death, allergy to opioids or drugs. Use of any investigational or prescription drugs within 30 days, any OTC drugs including herbal supplements within 14 days and drugs required to maintain regulation of bowel movements 48 hours before study day 1.
History of alcoholism within 1 month before study day 1, admitted alcohol abuse, or consumption of more than 2 standard units of alcohol per day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Cohn
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
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