Effect of Azimilide Dihydrochloride on Renal Function

This is a double-blind, parallel-group, placebo-controlled, multiple-dose, single-site study
in healthy male and female volunteers. Oral azimilide 125 mg or placebo will be administered
every 12 hours for 3 days, followed by 125 mg every 24 hours for 3 days. The study will
include a total of 21 healthy subjects (14 active and 7 placebo), all of whom will be
confined at the study center for 9 nights.

Inclusion Criteria:

- Male or hysterectomized or post-menopausal (last menstrual period > 1 year) female

- Between 18 and 45 years of age, inclusive, at screening

- In good general health based on medical history, physical examination and laboratory
evaluation

- Body mass index between 18 and 32 (kg/m2), inclusive

- Willing and able to fulfill the requirements of the protocol and provide written
consent

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.