View clinical trials related to Impaired Hepatic Function.
Filter by:This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (± 2 days) after initiation of study drug administration. Approximately 24 subjects will be enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for each of the 3 Child-Pugh categories of mild [5 - 6 points], moderate [7 - 9 points], and severe [10 - 15 points]) and 6 healthy subjects without hepatic impairment. Healthy subjects will be matched to hepatically impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).
Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe. Six patients will be enrolled inot each cohort and receive S-1.