Clinical trials: Severe Hepatic Impairment
Hepatic Function Abnormal
A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat.
- Trial name
- NCT05718258
- Testing
- Venglustat (GZ402671)
- Where
- 6 sites in United States, Germany
- Volunteers
- 26 people
- Sponsor
- Sanofi
Hepatic Impairment, Hepatic Function
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal…
- Trial name
- NCT02421042
- Testing
- Lenvatinib
- Where
- 5 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Advanced Solid Tumors, Hematologic Malignancies
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing…
- Trial name
- SPI-FOL-102 (NCT07036133)
- Testing
- Pralatrexate Injection
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Acrotech Biopharma Inc.
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic…
- Trial name
- NCT05935033
- Testing
- Emraclidine
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- AbbVie
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
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Metastatic Cancer
Pharmacokinetic and Safety Study of Pixantrone in Patients With Metastatic Cancer and Hepatic Impairment
This study will be conducted in patients with metastatic cancer and either moderate, severe, or no hepatic impairment who have failed other antineoplastic therapies or for whom there is no standard therapy.
- Trial name
- Hepatic (NCT01632436)
- Testing
- Pixantrone
- Where
- United States
- Sponsor
- CTI BioPharma
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x…
- Trial name
- NCT03423446
- Testing
- Telotristat Ethyl
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Hepatic Impairment
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
- Trial name
- NCT01727128
- Testing
- BKM120
- Where
- 3 sites in Bulgaria, Germany and 1 more
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers.
- Trial name
- HI (NCT01134185)
- Testing
- prucalopride
- Where
- Russia
- Volunteers
- 24 people
- Sponsor
- Movetis
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
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.
Hepatic Insufficiency, Blood Coagulation Disorders
Major Liver Resection: Early Clotting Disorders and Functional Impairment.
The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver…
- Trial name
- NCT02813538
- Testing
- Indocyanine green clearance, Thromboelastometry
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
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
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Trial name
- NCT06052566
- Testing
- Efinopegdutide
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteer Study, Hepatic Impairment
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Conditions
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- Trial name
- NCT06911320
- Testing
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Hepatic Impairment
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05707390
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment, Advanced Malignant Solid Tumor
A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function
This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe…
- Trial name
- NCT04241835
- Testing
- Tazemetostat
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 18 people
- Sponsor
- Epizyme, Inc.
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe…
- Trial name
- NCT05790304
- Testing
- Camizestrant
- Where
- 4 sites in United States, Bulgaria and 1 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AstraZeneca