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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01363323

Run by

Bausch Health Americas, Inc.

People needed

546

Starts

2004-11-01

Expected to finish

2005-02-01

Last updated by the study team

2019-11-29

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• Progenics Pharmaceuticals — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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