Clinical trials: Moderate Liver Impairment
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
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
Hepatic Function Abnormal
Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function
This is a Phase 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched…
- Trial name
- NCT05126329
- Testing
- amcenestrant
- Where
- 3 sites in Germany, South Korea
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Impairment
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with…
- Trial name
- NCT01027169
- Testing
- safinamide
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
Hepatic Insufficiency, Liver Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.
- Trial name
- NCT07853040
- Testing
- INCB161734
- Volunteers
- 24 people
- Sponsor
- Incyte Corporation
Hepatic Impairment, Healthy Volunteers
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
- Trial name
- NCT06352528
- Testing
- Repotrectinib
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Moderate Hepatic Impairment, Severe Hepatic Impairment
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Healthy Volunteers
- Trial name
- NCT05224609
- Testing
- Lorlatinib
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatitis C, Chronic
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and…
- Trial name
- NCT02864199
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 63 people
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment, Healthy Participants
An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
The purpose of this study is to investigate SHR3680 in participants with different levels of liver function
- Trial name
- NCT04631549
- Testing
- SHR3680
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Liver Dysfunction, Healthy Volunteers
An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage
The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.
- Trial name
- NCT03890809
- Testing
- BMS-986165
- Where
- 4 sites in Czechia, Hungary and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
Hepatitis B, Chronic, Chronic Kidney Diseases
Renoprotective Effects of Telbivudine in Chronic Hepatitis B
Renal impairment is common in patients with chronic hepatitis B infection. For those taking nucleotide analogues, renal toxicity of adefovir disoproxil (ADV) and tenofovir disoproxil fumarate (TDF) is a significant concern in…
- Trial name
- NCT03778567
- Testing
- Telbivudine
- Where
- Hong Kong
- Volunteers
- 31 people
- Sponsor
- The University of Hong Kong
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
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
Hepatic Insufficiency, Liver Diseases
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.
- Trial name
- NCT07559474
- Testing
- INCB123667
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
Liver Diseases, Digestive System Diseases
A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
This is a Phase 1, multicenter, nonrandomized, open-label, parallel-group study in participants with mild or moderate hepatic impairment, and in participants with normal hepatic function.
- Trial name
- NCT04639115
- Testing
- Ozanimod
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
Hepatic Insufficiency
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.
- Trial name
- NCT03341884
- Testing
- Ipatasertib
- Where
- 3 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Liver Diseases, Healthy
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control…
- Trial name
- NCT05731908
- Testing
- BI 690517
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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