Clinical trials: Hepatic Impairment
Hepatic Impairment, Healthy
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.
- Trial name
- NCT04494269
- Testing
- Tegoprazan 50mg
- Where
- 3 sites in South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
COVID-19
A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function.
- Trial name
- NCT05884554
- Testing
- PF-07817883
- Where
- 6 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
A Single and Repeat Dose Trial in Participants With Hepatic Impairment
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…
- Trial name
- NCT05009680
- Testing
- GB1211
- Where
- 4 sites in Bulgaria
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Galecto Biotech AB
Hepatic Impairment
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the…
- Trial name
- NCT02581592
- Testing
- TD-4208
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
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.
Prostate Cancer
A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and…
- Trial name
- NCT02001571
- Testing
- Abiraterone acetate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cougar Biotechnology, Inc.
Hepatic Impairment
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.
- Trial name
- NCT06388616
- Testing
- Balcinrenone
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment, Liver Disease
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment.
- Conditions
- Hepatic Impairment, Liver Disease, Pharmacokinetics
- Trial name
- NCT03765671
- Testing
- Elafibranor
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genfit
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms.
- Trial name
- NCT04903821
- Testing
- BAY3427080
- Where
- 2 sites in Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatitis C Virus
TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435.
- Trial name
- NCT01046058
- Testing
- TMC435
- Where
- 3 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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 Insufficiency, Renal Insufficiency
A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations
The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.
- Conditions
- Hepatic Insufficiency, Renal Insufficiency, Elderly
- Trial name
- NCT07345689
- Testing
- Anaprazole Sodium enteric-coated tablet
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams…
- Trial name
- NCT04953910
- Testing
- ASTX727
- Where
- 22 sites in United States, Armenia and 6 more
- Volunteers
- 27 people
- Sponsor
- Taiho Oncology, Inc.
Type2 Diabetes Mellitus
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg.
- Trial name
- NCT03557658
- Testing
- Bexagliflozin
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theracos
Hepatic Impairment, Healthy
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
- Trial name
- NCT02571816
- Testing
- ASP2215
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Insomnia, Hepatic Impairment
Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment
Primary Objectives: To evaluate the effect of the subjects with mild (Child Pugh A), moderate (Child Pugh B) and normal hepatic impairment on the pharmacokinetics of YZJ-1139 Secondary Objectives: To evaluate the safety of a…
- Trial name
- NCT06671509
- Testing
- YZJ-1139
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Hepatic Impairment
Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of hepatic impairment to healthy subjects.
- Trial name
- NCT01594957
- Testing
- LCQ908
- Where
- 2 sites in United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Insufficiency, Healthy
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female…
- Trial name
- NCT05440344
- Testing
- Imlunestrant
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus, Type 2
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing. The study will last for about 8 weeks.
- Trial name
- NCT04597697
- Testing
- Insulin icodec
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S
Overweight, Obesity
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function
The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people…
- Trial name
- NCT07587710
- Testing
- NNC0487-0111
- Where
- 2 sites in Slovakia
- Volunteers
- 35 people
- Sponsor
- Novo Nordisk A/S