Clinical trials: Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function
Hepatic Impairment
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to…
- Trial name
- NCT03282513
- Testing
- AG-120 (Ivosidenib)
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Advanced Solid Tumors, Hematologic Malignancies
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing…
- Trial name
- SPI-FOL-102 (NCT07036133)
- Testing
- Pralatrexate Injection
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Acrotech Biopharma Inc.
Healthy Volunteer
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched…
- Trial name
- NCT01197911
- Testing
- aleglitazar
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Insufficiency
A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver.
- Trial name
- NCT07401862
- Testing
- LY3841136
- Where
- 3 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function
The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to…
- Trial name
- NCT05674474
- Testing
- Vorasidenib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Institut de Recherches Internationales Servier
Hepatic Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function
- Trial name
- NCT03289234
- Testing
- MCI-186
- Where
- 2 sites in Japan
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Shionogi
Complement Mediated Primary or Secondary Glomerular Diseases
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06674915
- Testing
- HRS-5965 capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Hepatic Impairment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic…
- Trial name
- NCT03902002
- Testing
- Omaveloxolone 50 mg capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe…
- Trial name
- NCT01185873
- Testing
- danoprevir, ritonavir
- Where
- 5 sites in United States, Czechia and 1 more
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's lymphoma with or without impaired liver or kidney…
- Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma
- Trial name
- NCT00118170
- Testing
- sorafenib tosylate, pharmacological study
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Cancer Institute (NCI)
Carcinoma, Hepatocellular
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment
- Trial name
- NCT00437424
- Testing
- Brivanib
- Where
- 5 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb
Diabetes, Diabetes Mellitus, Type 2
Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Hepatic Impaired
- Trial name
- NCT02210871
- Testing
- semaglutide
- Where
- 4 sites in Poland, Slovakia
- Volunteers
- 44 people
- Sponsor
- Novo Nordisk A/S
Prevention of Thromboembolic Events, Atrial Fibrillation
A Study to Learn How the Study Treatment Asundexian Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body in Participants With Mild or Moderate Reduction of Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to prevent the formation of blood clots in people who have or have had: an irregular and often rapid heartbeat a blocked blood flow to the heart a blocked or reduced blood flow to a part…
- Conditions
- Prevention of Thromboembolic Events, Atrial Fibrillation, Acute Myocardial Infarction, Non-cardioembolic Ischemic Stroke
- Trial name
- NCT05419635
- Testing
- Asundexian (BAY2433334)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy, Hepatic Insufficiency
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy…
- Trial name
- NCT07165002
- Testing
- LY3537031
- Where
- 3 sites in Hungary, New Zealand and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Liver Diseases
A Research Study on Etavopivat in Participants With and Without Liver Disease
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls).
- Trial name
- NCT06336018
- Testing
- Etavopivat
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506
Moderate Hepatic Impairment Study Phase This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase: Cohort A: Subjects with moderate hepatic impairment Cohort…
- Trial name
- HS-10506-114 (NCT07844967)
- Testing
- HS-10506
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.