drugset / Trial / NCT01363323

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

NCT01363323

Phase 1 Completed 546 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-11
Primary completion
2005-01
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylnaltrexone Other / unclassified
Comparator Moxifloxacin Small molecule

Indications

No indication recorded.