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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
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: Methylnaltrexone (MNTX) Drug: Placebo Drug: Moxifloxacin Phase 1

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

Inclusion Criteria:

  1. Healthy and free of acute active illnesses
  2. Males and females between the ages of 18 and 45 years, inclusive
  3. Body mass index between 18-30, inclusive, and weight between 50-110 kgs
  4. ECG within normal limits (including PR <220, QRS <110, and QTc <450 ms.)

Exclusion Criteria:

  1. Previous MNTX exposure
  2. Currently pregnant or nursing
  3. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
  4. Consumption of alcoholic beverages within 7 days prior to study confinement
  5. Any evidence of congenital or familial long-QT syndrome
  6. History of drug abuse of positive findings on urine drug screen
  7. 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, New York
Progenics Pharmaceuticals
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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