Clinical trials: Hepatic Impairment
Diabetes Mellitus, Type 2
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants.
- Trial name
- NCT01767688
- Testing
- MK-3102
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy, Hepatic Insufficiency
A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function
The purpose of the study is to determine the concentration of canagliflozin in blood and urine samples after the administration of canagliflozin to study participants with mild or moderate hepatic (liver) impairment compared with…
- Trial name
- NCT01186588
- Testing
- Canagliflozin
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hepatic Impairment
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
This is an open-label, single-dose study designed to assess the pharmacokinetics and safety of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to those in subjects with normal hepatic function.
- Trial name
- NCT02296905
- Testing
- ABT-493, ABT-530
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AbbVie
Pain, Hepatic Impairment
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
Review differences between how a healthy person and how a person with liver problems handles the study drug.
- Trial name
- NCT00812305
- Testing
- SKY0402 300mg in healthy patients, SKY0402 300mg in hepatically impaired patients
- Where
- Poland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Chronic Hepatitis C
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
- Trial name
- NCT01817985
- Testing
- GS-5816
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy Volunteers, Hepatic Impairment
A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment
The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment
- Trial name
- NCT07248839
- Testing
- BMS-986435
- Where
- 3 sites in United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment, Healthy
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
- Trial name
- NCT01790607
- Testing
- ONO-2745 /CNS 7056
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ono Pharma USA Inc
Healthy, Hepatic Impairment
A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants
The main purpose of this study is to assess how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy…
- Trial name
- NCT05436912
- Testing
- Selpercatinib
- Where
- 7 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
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.
- Trial name
- NCT05376839
- Testing
- Cedirogant
- Where
- 3 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AbbVie
Liver Diseases, Healthy
A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m^2 can take part. Women can only participate if they cannot get pregnant.
- Trial name
- NCT06692322
- Testing
- Zongertinib
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
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.
Parkinson Disease
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina…
- Trial name
- NCT04724109
- Testing
- Equfina
- Where
- 2 sites in Japan
- Volunteers
- 1,088 people
- Sponsor
- Eisai Co., Ltd.
Hepatic Impairment, Healthy Volunteers
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic…
- Trial name
- NCT06535399
- Testing
- BMS-986369
- Where
- 3 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Celgene
Hepatic Insufficiency, Healthy
A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared…
- Trial name
- NCT06719128
- Testing
- Olomorasib
- Where
- 4 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment
This study is designed investigate the effect of severe hepatic impairment on the pharmacokinetics (PK) of cenobamate.
- Trial name
- NCT04791553
- Testing
- Cenobamate
- Where
- 2 sites in Poland, Slovakia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- SK Life Science, Inc.
COVID-19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06568861
- Testing
- ALG-097558
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Hepatic Impairment
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment and healthy volunteers.
- Trial name
- NCT02244827
- Testing
- WCK 2349
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.
- Trial name
- NCT03713242
- Testing
- ACT-541468 25 mg, ACT-541468 25 mg (or 10 mg depending on interim results)
- Where
- Switzerland
- Volunteers
- 32 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Worsening Chronic Heart Failure, Diabetic Nephropathy
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic…
- Trial name
- NCT04881994
- Testing
- Finerenone (BAY94-8862)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
Hepatic Impairment Trial of Obeticholic Acid
This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.
- Trial name
- NCT01904539
- Testing
- obeticholic acid 10 mg
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Intercept Pharmaceuticals