A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects...
PK of FG-4592Hepatic Insufficiency1 moreThe effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects. The results are compared to the data gained from subjects with normal liver function.
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency...
Renal InsufficiencyChronic2 moreAn open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label, crossover study in which they will receive Sporanox® to compare the safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and...
Liver DiseasesHepatic Encephalopathy1 moreThe purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic...
Hepatic InsufficiencyThis study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.
Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening...
Locally Advanced CancerMetastatic Cancer4 moreEvery day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department. Many studies suggest that providing palliative care to these patients may improve their end-of-life care while reducing costs by minimizing futile treatments and unwanted intensive care unit admissions. Consequently, there is a strong need for acute care hospitals to more vigorously identify patients entering the final phase of their lives as well as their specific care needs. In a previous study the investigators screened for need of palliative care patients affected by progressive chronic diseases by means of a tool, based on the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care - SIAARTI - position paper reporting criteria for patients with end-stage chronic organ failures, and on the specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN) for patients with locally advanced/metastatic cancer. In a further pilot study, the investigators compared the outcomes of PC patients depending on whether the palliative care team evaluated such patients only if requested by the physician staff or routinely, irrespectively of a specific request, finding a significant increase of discharges after the activation of an appropriate PC service or scheduled PC ambulatory visit. In the present study the investigators enroll chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, to be screened for palliative care need, using the previously cited SIAARTI/NCCN screening tool (Extended Screening Tool - EST), or using a Simplified Screening Tool (SST), derived from the first instrument, which preliminary showed a superimposable efficacy. This latter tool has advantages related to much more shortness and therefore simplicity in the administration to a seriously ill patient and is much less time consuming, allowing the physician to use it routinely. The aim of the study is to verify the accuracy of the SST in identifying chronically ill patients in need of a PC approach, in comparison to the SIAARTI/NCCN tool (EST). If the SST would show good accuracy, an easily manageable tool for the assessment of PC needs in chronically ill patients would be available for the daily routine.
Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency...
Hepatic InsufficiencyThis is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib...
HealthyHepatic InsufficiencyThis is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver...
Hepatic InsufficiencyThe purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
Hepatic InsufficiencyThe purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
Hepatic InsufficiencyThe study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated. This study will last approximately 3 weeks for each participant, including check-in and follow-up.