Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization

This study has been completed.

Sponsor:

Information provided by:

Valeant Pharmaceuticals International, Inc.

ClinicalTrials.gov Identifier:

NCT01363323

First received: May 27, 2011

Last updated: July 17, 2011

Last verified: July 2011

History of Changes

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 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:

Drug Information available for: Methylnaltrexone

U.S. FDA Resources

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:

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.


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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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


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

Additional relevant MeSH terms:


Methylnaltrexone Naltrexone Moxifloxacin Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents	Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on June 22, 2017

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