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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Methylnaltrexone (MNTX); Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT01363323
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-01
• Study Completion: 2005-02
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-06-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Methylnaltrexone (MNTX)	-
Arm 3	Methylnaltrexone (MNTX)	-
Arm 4	Placebo	-
Arm 5	Moxifloxacin	-
Arm 1	Methylnaltrexone (MNTX)	-

Primary Outcome Measures

Name	Time	Method
Effects of MNTX on QTcI duration	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.

Trial Locations

Locations (1)

Progenics Pharmaceuticals; 🇺🇸 Tarrytown, New York, United States