Clinical trials: Moderate Hepatic Impairment
Diabetes, Diabetes Mellitus, Type 2
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT02016911
- Testing
- semaglutide
- Where
- 6 sites in Czechia, Poland and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Liver Dysfunction, Healthy
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild…
- Trial name
- NCT06916078
- Testing
- Lepodisiran
- Where
- 4 sites in United States, Hungary
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment
To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics and their metabolites following administration of CPX-351.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02269579
- Testing
- CPX-351
- Where
- 5 sites in United States
- Sponsor
- Jazz Pharmaceuticals
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.
Patients with Mild or Moderate Hepatic Impairment
A Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment
This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment
- Trial name
- NCT05624944
- Testing
- TS-142 5 mg
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Hepatic Impairment
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
- Trial name
- NCT02004587
- Testing
- Gemigliptin
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Normal Hepatic Function, Impaired Hepatic Function
Effect of Hepatic Impairment on LDE225..
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- NCT01764776
- Testing
- LDE225
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Moderate Hepatic Impairment
A Study of Belzutifan (MK-6482) in Participants With Hepatic Impairment (MK-6482-020)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched…
- Trial name
- NCT04995484
- Testing
- Belzutifan
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
Pharmacokinetics of AGO178 in Participants With Liver Impairment
AGO178 was developed for the treatment of depression. A new formulation is being tested in the present study: a tablet to be placed and dissolved under the tongue (sublingual tablet).
- Trial name
- NCT01531309
- Testing
- AGO178
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
Hepatic Impairment
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
- Trial name
- NCT05078580
- Testing
- Iptacopan
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
- Trial name
- NCT01571388
- Testing
- dacomitinib
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700
- Trial name
- NCT03189615
- Testing
- Lu AF35700
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck 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.
Liver Diseases, Healthy
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched…
- Trial name
- NCT01298063
- Testing
- Afatinib
- Where
- Germany
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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 Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
- Trial name
- NCT05409911
- Testing
- S-217622
- Where
- 4 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Shionogi
Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with…
- Conditions
- Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancers
- Trial name
- NCT06682988
- Testing
- Mirvetuximab Soravtansine
- Where
- 52 sites in United States, Australia and 6 more
- Volunteers
- 110 people
- Sponsor
- AbbVie
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
Early Alzheimer's Disease
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
- Trial name
- NCT02859207
- Testing
- E2609
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.