NCT01363323

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Methylnaltrexone (MNTX)	Dose 1
DRUG	Methylnaltrexone (MNTX)	Dose 2
DRUG	Methylnaltrexone (MNTX)	Dose 3
DRUG	Placebo
DRUG	Moxifloxacin

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-01-01
• Completion: 2005-02-01
• First posted: 2011-06-01
• Last updated: 2019-11-29

Locations

1 site across 1 country: United States