Clinical trials: Hepatic Impairment
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 Impairment
A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)
The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants.
- Trial name
- NCT04676425
- Testing
- Elpipodect
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Purpura, Thrombocytopaenic, Idiopathic
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems.
- Trial name
- NCT00359463
- Testing
- eltrombopag
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Sepsis
A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids are broken down in the body by the liver.
- Trial name
- NCT00158769
- Testing
- Intravenous GR270773 - Phospholipid emulsion
- Where
- Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Knee Osteoarthritis
Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.
- Trial name
- NCT02456688
- Testing
- Imrecoxib
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Impairment
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment
Comparison of the pharmacokinetics/Pharmacodynamics of the HSK3486 in Patients With Mild and Moderate Hepatic Impairment Compared with Healthy Volunteers
- Trial name
- NCT04145596
- Testing
- HSK3486
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Hepatic Failure
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
- Trial name
- NCT04587622
- Testing
- Icenticaftor
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Advanced or Metastatic Solid Tumor, Liver Failure
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
- Trial name
- NCT04617522
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 15 sites in United States, France and 2 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Healthy, Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-42847922 in adult participants with hepatic impairment when compared to healthy participants with normal hepatic function.
- Trial name
- NCT04960124
- Testing
- JNJ-42847922
- Where
- 2 sites in Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Impaired Hepatic Function
Evaluating Patients With Impaired Hepatic Function
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic…
- Trial name
- NCT00398424
- Testing
- S-1/Cisplatin
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
Clinical Pharmacology
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight
BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease.
- Trial name
- NCT04366622
- Testing
- Riociguat (Adempas, BAY 63-2521)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose…
- Trial name
- NCT05706623
- Testing
- Apraglutide
- Where
- 2 sites in Germany, Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VectivBio AG
Hepatic Impairment
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)
- Trial name
- NCT06161259
- Testing
- Leritrelvir(Ray1216)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
BRAF V600 Mutation, Unresectable Melanoma
Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Encorafenib in combination with binimetinib have been approved in USA, Europe, Australia, Japan and Switzerland for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation.
- Conditions
- BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma, Hepatic Impairment
- Trial name
- NCT04759846
- Testing
- Encorafenib + Binimetinib
- Where
- 7 sites in Czechia, Italy and 1 more
- Sponsor
- Pierre Fabre Medicament
Hepatic Impairment, Healthy Volunteers
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with mild and moderate hepatic impairment compared to healthy…
- Trial name
- NCT04482270
- Testing
- fezolinetant
- Where
- 4 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Impairment, Healthy Subjects
The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics
This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).
- Trial name
- NCT04252495
- Testing
- Aprocitentan
- Where
- 2 sites in Germany, Poland
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Hepatic Impairment
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
- Trial name
- NCT03160014
- Testing
- SHR3824
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Impairment
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib
This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by…
- Trial name
- NCT02621047
- Testing
- Alectinib
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy, Hepatic Impairment
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver)…
- Trial name
- NCT07219550
- Testing
- Calderasib
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC