Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function

Completed · Phase 1

Conditions studied: Long QT Syndrome

In brief

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral eleclazine and its metabolite, GS-623134, in participants with normal and impaired hepatic function. Participants in the healthy control group will be matched to participants with impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).

Key facts

Study ID

NCT02412098

Run by

Gilead Sciences

People needed

49

Starts

2015-03-19

Expected to finish

2016-04-22

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — München, Germany
• Study site — Auckland, New Zealand
• Study site — Bucharest, Romania

Full record on ClinicalTrials.gov

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