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Hepatic Impairment clinical trials

View clinical trials related to Hepatic Impairment.

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NCT ID: NCT01516047 Completed - Hepatic Impairment Clinical Trials

A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function

Start date: January 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation.

NCT ID: NCT01493869 Completed - Healthy Clinical Trials

Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects

Start date: September 2011
Phase: Phase 1
Study type: Interventional

The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.

NCT ID: NCT01456663 Completed - Hepatic Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Start date: May 2011
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.

NCT ID: NCT01443481 Completed - Solid Tumors Clinical Trials

Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.

NCT ID: NCT01433458 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects. 20 to 24 patients and 20 to 24 healthy subjects will be enrolled.

NCT ID: NCT01431833 Completed - Hepatic Impairment Clinical Trials

A PK and Safety Study in Subjects With Hepatic Impairment

Start date: August 2011
Phase: Phase 1
Study type: Interventional

Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

NCT ID: NCT01429337 Completed - Hepatic Impairment Clinical Trials

PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function

Start date: March 7, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.

NCT ID: NCT01419457 Completed - Healthy Clinical Trials

Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.

NCT ID: NCT01319279 Completed - Hepatic Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment

Start date: April 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is: 1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.

NCT ID: NCT01271387 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.