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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Methylnaltrexone (MNTX); Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363323

MNTX 1106

Details and patient eligibility

About

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.

Enrollment: 546 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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546 participants in 5 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Arm 2

Experimental group

Treatment:

Drug: Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Arm 3

Experimental group

Treatment:

Drug: Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Drug: Methylnaltrexone (MNTX)

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 5

Active Comparator group

Treatment:

Drug: Moxifloxacin