Clinical trials: Hepatic Impairment
Advanced Cancers
Hepatic Impairment Study for Lorlatinib in Cancer Patients
This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients…
- Trial name
- NCT03726333
- Testing
- lorlatinib
- Where
- 10 sites in United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Hepatic Impairment
A Study of RAY1225 in Participants With Impaired Liver Function
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.
- Trial name
- NCT06577415
- Testing
- RAY1225
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Hepatic Impairment
Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543
This is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following…
- Trial name
- NCT05467722
- Testing
- CTP-543
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Hepatic Impairment
Study to Evaluate the Safety, Tolerability, and PK of Pacritinib
This is a Phase 1 study designed to assess the effect of hepatic insufficiency on the PK of pacritinib by study of 14-day BID dosing of pacritinib in subjects with moderate and severe hepatic impairment compared to healthy…
- Trial name
- NCT05552183
- Testing
- oral dose of 200 mg pacritinib twice daily (BID)
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Healthy
Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine
This study will assess the influence of moderate hepatic impairment on the pharmacokinetics of licarbazepine after single oral administration in healthy subjects and in subjects with stable impaired hepatic function.
- Trial name
- NCT00424671
- Testing
- Licarbazepine
- Where
- Czechia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis
Hepatic Impairment
A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function
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.
- Trial name
- NCT02372084
- Testing
- osilodrostat
- Where
- 3 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects
- Trial name
- NCT01621633
- Testing
- LCZ696
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Moderate Hepatic Impairment, Severe Hepatic Impairment
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Liver Diseases
- Trial name
- NCT05116826
- Testing
- Nitazoxanide
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Genfit
Hepatic Impairment
Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to…
- Trial name
- NCT01271387
- Testing
- tasimelteon
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Liver Diseases
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: stable loss of liver function with mild or moderate severity none of…
- Trial name
- NCT06340347
- Testing
- Osivelotor
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pfizer
Heptic Impairment
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
- Trial name
- NCT02231450
- Testing
- Lu AE58054 encapsulated film-coated tablets
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Hepatic Impairment and Healthy Female
GS1-144 in Participants With Hepatic Impairment and Healthy Female
GS1-144 in Participants with Hepatic Impairment and Healthy Female
- Trial name
- NCT07491289
- Testing
- GS1-144 tablet
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Participants
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100
- Trial name
- NCT05537142
- Testing
- BV100
- Where
- Hungary
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- BioVersys AG
Migraine
Pharmacokinetic Single Dose Study of Oral Lasmiditan in Participants With Normal and Impaired Hepatic Function
This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with…
- Trial name
- NCT03040479
- Testing
- lasmiditan 200 mg
- Where
- 3 sites in United States, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- CAMPOLINA (NCT06812780)
- Testing
- AZD2389
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Diabetes Mellitus, Type 2
To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT05747664
- Testing
- DWP16001
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
HIV-1-infection, Hepatic Impairment
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the…
- Trial name
- NCT03706898
- Testing
- Elpida®, Dolutegravir, Sofosbuvir
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Viriom
Hepatic Impairment (HI)
A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)
The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control…
- Trial name
- NCT06442436
- Testing
- Nemtabrutinib
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI)…
- Trial name
- NCT03369002
- Testing
- seladelpar
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences