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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363323
• Other study ID #: MNTX 1106
• Status: Completed
• Phase: Phase 1
• Start date: November 2004
• Est. completion date: February 2005

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: February 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Methylnaltrexone (MNTX)
Dose 1
• Methylnaltrexone (MNTX)
Dose 2
• Methylnaltrexone (MNTX)
Dose 3
• Placebo

• Moxifloxacin

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of MNTX on QTcI duration	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.	3 days