View clinical trials related to Severe Hepatic Impairment.
Filter by:The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants. This study is seeking participants who: - Must be male or female of 18 to 75 years of age, inclusive at the time of the study. - Are willing and able to comply with all scheduled visits, treatment plan, and other study procedures. - Have a BMI (body mass index) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb). - Are capable of giving signed informed consent document. All participants in this study will receive Lorlatinib. Participants will be placed into 1 of 3 cohorts based on their hepatic (liver) function. Participants will take Lorlatinib once by mouth. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. Participants will take part in this study for up to 35 days.
Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet the full study eligibility criteria will be enrolled into the study. For each participant with severe hepatic impairment, a corresponding healthy participant will be enrolled who matches with regard to age, sex, and BMI. A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments. The study will measure and describe the concentrations of EQ143 and its metabolite (HAS-719) in plasma over the course of 9 days (including calculation of PK parameters), the degree of EQ143 and metabolite HAS-719 (and other metabolites, if applicable) binding to proteins in plasma, and the safety of administering a single dose of EQ143 in severely hepatically impaired and matched healthy participants
This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
The primary objective of this study is to characterize the steady state plasma
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy participants.
The influence of severely diminished liver function on the metabolism, safety, and tolerability of a single oral dose of enzalutamide in a group of 8 men. The results are compared to the data gained from 8 age- and BMI-matched men with normal liver function.