Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
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ClinicalTrials.gov Identifier: NCT01363323 |
Recruitment Status
:
Completed
First Posted
: June 1, 2011
Last Update Posted
: July 19, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: Methylnaltrexone (MNTX) Drug: Placebo Drug: Moxifloxacin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 546 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | January 2005 |
Actual Study Completion Date : | February 2005 |

Arm | Intervention/treatment |
---|---|
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 |
- Effects of MNTX on QTcI duration [ Time Frame: 3 days ]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.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363323
United States, New York | |
Progenics Pharmaceuticals | |
Tarrytown, New York, United States, 10591 |
Study Director: | Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. |
Responsible Party: | Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01363323 History of Changes |
Other Study ID Numbers: |
MNTX 1106 |
First Posted: | June 1, 2011 Key Record Dates |
Last Update Posted: | July 19, 2011 |
Last Verified: | July 2011 |
Additional relevant MeSH terms:
Moxifloxacin Methylnaltrexone Naltrexone Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |