Effect of Azimilide Dihydrochloride on Renal Function

Exclusion Criteria

• •History of diabetes, cardiovascular, hepatic, renal, or gastrointestinal disease
• •History of use of tobacco or nicotine-containing products within the past 3 months
• •Alcohol or illicit drug abuse or a reported habitual alcohol intake greater than 1.5 oz. (ethanol equivalent) per day (e.g., 24 ozs. of beer, 10 ozs. of wine, or 3 ozs. of hard liquor) within the past 2 years.
• •History of a clinically significant (in the opinion of the investigator) allergic reaction to any drug or multiple food/drug, contrast media agents, PAH, iodine or shell fish.
• •Clinically significant abnormality upon physical examination that, in the investigator's opinion, would interfere with the conduct of the study
• •Corrected QT-interval (QTc) \> 440 msec (QT interval corrected for heart rate using Bazett's formula).
• •Clinically significant abnormality on screening 12-lead electrocardiogram (ECG); presence of discernable U wave that (in the investigator's opinion) would interfere with accurate measurement of QT at baseline and/or after treatment.
• •Personal or family history of long QT syndrome
• •Absolute neutrophil count \< 1500/mm3
• •Potassium or magnesium value(s) outside the laboratory normal range
• •Any other laboratory value(s) outside the laboratory normal range considered clinically significant by the investigator (serum chemistry, hematology, coagulation, or urinalysis.
• •Serology positive for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) screen.
• •If female, positive urine or serum pregnancy test
• •Positive urine screen for drugs of abuse
• •Reported use of any prescription drug or herbal preparations within 14 days prior to dosing or any non-prescription drug or vitamin within 7 days prior to dosing.
• •Reported use of any known enzyme-inducer, enzyme-inhibitor, or other investigational drug within 30 days prior to dosing, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of dosing.
• •Blood donation of approximately 400 mL or more within 4 weeks or plasma donation of 200 mL or more within 2 weeks prior to dosing.
• •Acute illness within 2 weeks prior to dosing
• •History or presence, upon clinical evaluation, of any illness that might impact the safety of test product administration or evaluability of drug effect based on the investigator's discretion.
• •Has participated in another investigational drug study protocol within 30 days of admission.