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Hepatic Impairment clinical trials

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NCT ID: NCT05582187 Active, not recruiting - Hepatic Impairment Clinical Trials

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in People With Hepatic Dysfunction.

Start date: October 31, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to understand how fosmanogepix is processed in people with varying degrees of liver dysfunction. This study is seeking participants who have: - stable loss of liver function with mild, moderate, or advanced severity - none of underlying conditions possibly affecting the study medicine being absorbed by the body - liver dysfunction not due to acute worsening of liver All participants will receive 1 dose of fosmanogepix by mouth before breakfast on the first day at the study clinic. Serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe. Participants will be involved in this study for 4 to 9 weeks (maximum). There will be 2 to 4 study visits at the study clinic.

NCT ID: NCT05009680 Active, not recruiting - Hepatic Impairment Clinical Trials

A Single and Repeat Dose Trial in Participants With Hepatic Impairment

Start date: September 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh B and Child Pugh C)

NCT ID: NCT04305392 Active, not recruiting - Hepatic Impairment Clinical Trials

Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment

Start date: August 4, 2020
Phase: Phase 1
Study type: Interventional

Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.

NCT ID: NCT04020016 Active, not recruiting - Hepatic Impairment Clinical Trials

Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch

Start date: October 24, 2018
Phase: Phase 1
Study type: Interventional

This research study will evaluate the effect of liver disease on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER), tablets in people with liver disease (mild, moderate and severe), compared to people with normal liver function. The study will also test the safety and tolerability of the NAL ER, when it is given to subjects with mild, moderate and severe liver disease, compared to subjects with normal liver function. This protocol will also study the effects of this drug on itching in liver disease subjects if they report some itching prior to taking part in this study.