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Hepatic Impairment clinical trials

View clinical trials related to Hepatic Impairment.

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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.

NCT ID: NCT02121860 Completed - Liver Diseases Clinical Trials

PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers

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

This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.

NCT ID: NCT02115347 Completed - Clinical trials for Type 2 Diabetes Mellitus

Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)

Start date: September 19, 2014
Phase: Phase 1
Study type: Interventional

This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1 of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).

NCT ID: NCT02095587 Completed - Hepatic Impairment Clinical Trials

Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

IPI-145-14
Start date: March 2014
Phase: Phase 1
Study type: Interventional

To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

NCT ID: NCT02050815 Terminated - Hepatic Impairment Clinical Trials

MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function

MEK162
Start date: March 2014
Phase: Phase 1
Study type: Interventional

This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with normal hepatic function. Subjects will be assigned by hepatic function defined by elevation of serum total bilirubin and serum AST as determined at the screening and baseline visits. The study population will be healthy male and postmenopausal or sterile female subjects who meet all of the inclusion and none of the exclusion criteria. A minimum of 24 evaluable subjects (6 subjects per group) will be enrolled. The groups are: Group 1-healthy volunteers, Group 2-Mild hepatic impairment, Group 3-Moderate hepatic impairment and Group 4-Severe hepatic impairment. Once approved for enrollment, participants will be confined to the facility for 5 days, given a single dose of MEK162 and monitored for safety assessments, labs and PK will be assessed.

NCT ID: NCT02004587 Completed - Hepatic Impairment Clinical Trials

Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers

Start date: September 2013
Phase: Phase 1
Study type: Interventional

The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.

NCT ID: NCT01984736 Completed - Hepatic Impairment Clinical Trials

EVP-6124 Hepatic Impairment Study

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.