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Hepatic Impairment clinical trials

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NCT ID: NCT02421042 Completed - Hepatic Impairment Clinical Trials

A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)

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

This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal healthy subjects as controls.

NCT ID: NCT02372084 Completed - Hepatic Impairment Clinical Trials

A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function

Start date: April 21, 2015
Phase: Phase 1
Study type: Interventional

To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.

NCT ID: NCT02367872 Completed - Hepatic Impairment Clinical Trials

Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.

NCT ID: NCT02296905 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function

Start date: October 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose study designed to assess the pharmacokinetics and safety of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to those in subjects with normal hepatic function. Twenty-four subjects will be selected and enrolled according to the subject selection criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).

NCT ID: NCT02286609 Completed - Hepatic Impairment Clinical Trials

A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics

Start date: December 2014
Phase: Phase 1
Study type: Interventional

This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age, body mass index [BMI], and gender).

NCT ID: NCT02256033 Completed - Hepatic Impairment Clinical Trials

Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test whether mild liver impairment affects blood levels of istradefylline in humans. Decreased liver function could possibly increase istradefylline levels.

NCT ID: NCT02245243 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

Start date: September 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment.

NCT ID: NCT02244827 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Start date: September 2014
Phase: Phase 1
Study type: Interventional

This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment and healthy volunteers.

NCT ID: NCT02242734 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment

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

Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules

NCT ID: NCT02150733 Completed - Cancer Clinical Trials

Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment

Start date: April 2014
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of hepatic function, from normal to severely impaired.