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Completed

NCT Number: NCT01363323

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylnaltrexone (MNTX)

Drug

Dose 1

Placebo

Drug

moxifloxacin

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 1, 2011
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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