Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
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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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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.)
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.