Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
This study has been completed.
Sponsor:
Salix Pharmaceuticals
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00444158
First received: March 5, 2007
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Drug: MOA-728 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
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.
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jeff Cohn, Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00444158 History of Changes |
| Other Study ID Numbers: | 3200L2-1108 |
| Study First Received: | March 5, 2007 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
opioids chronic pain |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Methadone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013