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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
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
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:

U.S. FDA Resources

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:

  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
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
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013