Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
This study has been completed.
Sponsor:
Salix Pharmaceuticals
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01363323
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
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Purpose
This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Methylnaltrexone (MNTX) Drug: Placebo Drug: Moxifloxacin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
Primary Outcome Measures:
- Effects of MNTX on QTcI duration [ Time Frame: 3 days ] [ Designated as safety issue: No ]The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers.
| Enrollment: | 546 |
| Study Start Date: | November 2004 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Methylnaltrexone (MNTX)
Dose 1
|
| Experimental: Arm 2 |
Drug: Methylnaltrexone (MNTX)
Dose 2
|
| Experimental: Arm 3 |
Drug: Methylnaltrexone (MNTX)
Dose 3
|
| Placebo Comparator: Arm 4 | Drug: Placebo |
| Active Comparator: Arm 5 | Drug: Moxifloxacin |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy and free of acute active illnesses
- Males and females between the ages of 18 and 45 years, inclusive
- Body mass index between 18-30, inclusive, and weight between 50-110 kgs
- ECG within normal limits (including PR <220, QRS <110, and QTc <450 ms.)
Exclusion Criteria:
- Previous MNTX exposure
- Currently pregnant or nursing
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
- Consumption of alcoholic beverages within 7 days prior to study confinement
- Any evidence of congenital or familial long-QT syndrome
- History of drug abuse of positive findings on urine drug screen
- Known allergy or hypersensitivity to MNTX or its excipients, moxifloxacin, opioids, or related drugs or a history or relevant adverse drug reactions of any origin.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363323
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363323
Locations
| United States, New York | |
| Progenics Pharmaceuticals | |
| Tarrytown, New York, United States, 10591 | |
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
| Study Director: | Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01363323 History of Changes |
| Other Study ID Numbers: | MNTX 1106 |
| Study First Received: | May 27, 2011 |
| Last Updated: | July 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Methylnaltrexone Naltrexone Central Nervous System Agents Narcotic Antagonists Peripheral Nervous System Agents |
Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015