Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function

Inclusion Criteria:

All participants:

- 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 study
screening

- Have a creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method)
based on serum creatinine and actual body weight as measured at screening

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

- Screening labs within defined thresholds

Participants with mild, moderate, or severe hepatic impairment must also meet the
following additional inclusion criteria:

- Must have diagnosis of chronic (> 6 months), stable hepatic impairment with no
clinically significant changes within 3 months (90 days) prior to study drug
administration (Day 1)

- Individuals with severe hepatic impairment must have a score on the
Child-Pugh-Turcotte scale of 10-15 at screening. If an individual's score changes
during the course of the study, the score at screening will be used for
classification.

- Individuals with moderate hepatic impairment must have a score on the
Child-Pugh-Turcotte scale of 7-9 at screening. If an individual's score changes
during the course of the study, the score at Screening will be used for
classification.

- Individuals with mild hepatic impairment must have a score on the Child-Pugh-Turcotte
scale of 5-6 at screening. If an individual's score changes during the course of the
study, the score at screening will be used for classification.

Exclusion Criteria:

- Pregnant or lactating females

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

- Presence or history of cardiovascular disease (including history of myocardial
infarction based on ECG and/or clinical history, any history of ventricular
tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection
fraction < 40%), cardiac conduction abnormalities, a family history of Long QT
Syndrome, 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

- Are unable to comply with study requirements or are otherwise believed, by the study
investigator, to be inappropriate for study participation for any reason

- Active hepatitis B virus (HBV) infection. Individuals who have HBsAg are ineligible

- Requires paracentesis > 1 time per month

- Severe (grade 3 or 4) encephalopathy as judged by the investigator

- History of gastric or esophageal variceal bleeding within the past 6 months and for
which varices have not been adequately treated with medication and/or surgical
procedures