Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function

Inclusion Criteria: All Individuals:

• Be a nonsmoker or consume < 20 cigarettes per day

• Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at studyscreening

• Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities thatare considered clinically insignificant by the investigator

• Screening labs within defined thresholds Individuals with mild, moderate, or severe renal impairment must also meet the followingadditional inclusion criteria to be eligible for participation in this study:

• Must have diagnosis of chronic (> 6 months), stable renal impairment with noclinically significant changes within 3 months (90 days) prior to study drugadministration (Day 1)

• Individuals with severe renal impairment, creatinine clearance (CLcr) must be 15-29mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine andactual body weight as measured at the screening evaluation. If an individual's scorechanges during the course of the study, the score at screening will be used forclassification.

• Individuals with moderate renal impairment, CLcr must be 30-59 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight asmeasured at the screening evaluation. If an individual's score changes during thecourse of the study, the score at screening will be used for classification.

• Individuals with mild renal impairment , CLcr must be 60-89, inclusive mL/min (usingthe Cockcroft-Gault method) based on serum creatinine and actual body weight asmeasured at the screening evaluation. If an individual's score changes during thecourse of the study, the score at screening will be used for classification. Individuals with normal renal function must also meet the following additional inclusioncriteria to be eligible for participation in this study:

• Must, in the opinion of the Investigator, be in good health based upon medicalhistory, physical examination, vital signs, and screening laboratory evaluations

• Must have an CLcr of ≥ 90 mL/min (using the Cockcroft-Gault method) based on serumcreatinine and actual body weight as measured at the screening evaluation.

Exclusion Criteria:

• History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors,myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuriesor a family history of seizures

• Presence or history of cardiovascular disease (including history of myocardialinfarction based on ECG and/or clinical history, any history of ventriculartachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejectionfraction < 40%), cardiac conduction abnormalities, a family history of Long QTSyndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years

• Syncope, palpitations, or unexplained dizziness

• Implanted defibrillator or pacemaker

• Medical history of renal carcinoma or hepatorenal syndrome.

• Individuals receiving or anticipating use of hemodialysis, peritoneal dialysis, or anyother renal replacement therapy or other medical procedure that serves as a surrogatefor renal function during the study.

• Individuals with fluctuating or rapidly deteriorating renal function. Assessment ofthe stability of the individual's renal function will be determined by theinvestigator.

• Renal allograft recipients

• Experienced hypertensive crisis, required the addition of ≥1 antihypertensive drug, orrequired more intensive antihypertensive therapy (eg, addition of a new drug class) inthe last 3 months