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Hepatic Impairment clinical trials

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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: 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.

NCT ID: NCT01949545 Completed - Solid Tumors Clinical Trials

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment

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

The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.

NCT ID: NCT01904539 Completed - Hepatic Impairment Clinical Trials

Hepatic Impairment Trial of Obeticholic Acid

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

This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.

NCT ID: NCT01888393 Completed - Healthy Clinical Trials

Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects

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

This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.

NCT ID: NCT01887301 Completed - Hepatic Impairment Clinical Trials

Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients

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

A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver) function impairment.

NCT ID: NCT01863784 Completed - Hepatic Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function

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

The purpose of this study is to characterize the pharmacokinetics (what the body does to the study medication) of JNJ-38518168 at approximately steady-state (stable medication levels) after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild or moderate hepatic (liver) impairment (abnormal function) compared with participants with normal hepatic function.