Phase 1
Completed N=49
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function
Long QT Syndrome
Source: ClinicalTrials.gov NCT02412098 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine — 42503.2; 50064.7; 57795.9; 39173.2 h*ng/mL
Summary
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%).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine |
42503.2; 50064.7; 57795.9; 39173.2 | — |
| PRIMARY PK Parameter: AUCinf of GS-623134 (Metabolite of Eleclazine) |
1880.0; 1983.2; 2326.2; 2697.4 | — |
| PRIMARY PK Parameter: Cmax of Eleclazine |
214.9; 338.1; 322.9; 331.3 | — |
| PRIMARY PK Parameter: Cmax of GS-623134 (Metabolite of Eleclazine) |
4.9; 7.3; 6.5; 10.2 | — |
| SECONDARY Number of Participants Experiencing Treatment-Emergent Adverse Events |
6; 8; 3 | — |
| SECONDARY Number of Participants Experiencing Clinical Laboratory Abnormalities |
0; 1; 0; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
All participants:
- Be a nonsmoker or consume 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 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
Data sourced from ClinicalTrials.gov (NCT02412098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.