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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Methylnaltrexone (MNTX)

Intervention Type DRUG

Dose 1

Arm 2

Group Type EXPERIMENTAL

Methylnaltrexone (MNTX)

Intervention Type DRUG

Dose 2

Arm 3

Group Type EXPERIMENTAL

Methylnaltrexone (MNTX)

Intervention Type DRUG

Dose 3

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Arm 5

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Interventions

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Methylnaltrexone (MNTX)

Dose 1

Intervention Type DRUG

Methylnaltrexone (MNTX)

Dose 2

Intervention Type DRUG

Methylnaltrexone (MNTX)

Dose 3

Intervention Type DRUG

Placebo

Intervention Type DRUG

Moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes