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Hepatic Impairment clinical trials

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NCT ID: NCT05517226 Terminated - Hepatic Impairment Clinical Trials

Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment

Start date: September 6, 2022
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal hepatic function.

NCT ID: NCT05376839 Terminated - Hepatic Impairment Clinical Trials

A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment

Start date: July 6, 2022
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.

NCT ID: NCT04332523 Terminated - Hepatic Impairment Clinical Trials

A Study of JNJ-53718678 in Participants With Hepatic Impairment

Start date: August 17, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.

NCT ID: NCT03587363 Terminated - Hepatic Impairment Clinical Trials

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib

Start date: December 6, 2018
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.

NCT ID: NCT03212313 Terminated - Hepatic Impairment Clinical Trials

Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

Start date: June 30, 2017
Phase: Phase 1
Study type: Interventional

This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.

NCT ID: NCT02873650 Terminated - Hepatic Impairment Clinical Trials

Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

Start date: December 20, 2016
Phase: Phase 1
Study type: Interventional

To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.

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.