Clinical trials: Hepatic Impairment
Hepatic Impairment
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
- Trial name
- NCT06740799
- Testing
- Quizartinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Hepatic Impairment
DZD9008 PK Study in Hepatic Impairment Subjects
This study will investigate the pharmacokinetics, safety, and tolerability of DZD9008 in subjects with hepatic impairment compared to subjects with normal hepatic function
- Trial name
- NCT06084104
- Testing
- DZD9008
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Dizal Pharmaceuticals
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects
This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
- Trial name
- NCT01456663
- Testing
- AFQ056
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Analgesic Allergy
Pharmacokinetic Study of Intranasal RX0041-002 in Hepatic-Impaired Individuals and Subjects With Normal Hepatic Function
The primary objective of this study is to evaluate the potential effect of hepatic impairment on the systemic pharmacokinetics of RX0041-002 following single dose intranasal administration.
- Trial name
- NCT02775981
- Testing
- RX0041-002
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Project Solutions, Inc.
Hepatic Impairment
A Study About Fazirsiran in People With and Without Liver Problems
The main aim of this study is to learn how the body processes fazirsiran (pharmacokinetics [PK]) in people with mild, moderate, or severe liver problems, compared to people with normal liver function.
- Trial name
- NCT05891158
- Testing
- Fazirsiran
- Where
- 4 sites in Hungary, Slovakia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Takeda
Hepatic Impairment
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT04552808
- Testing
- Yimitasvir Phosphate
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Prostate Cancer
A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and…
- Trial name
- NCT02001571
- Testing
- Abiraterone acetate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cougar Biotechnology, Inc.
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety of HSK31858 in subjects with mild, moderate, severe hepatic impairment and normal hepatic function.
- Trial name
- NCT07913009
- Testing
- HSK31858 tablets
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Advanced Cancer
Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients
This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients.
- Trial name
- NCT01576406
- Testing
- crizotinib
- Where
- 20 sites in United States
- Volunteers
- 88 people
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
The study is divided into two parts - Part A and Part B. Cagrilintide in combination with semaglutide, is under development for weight management.
- Trial name
- NCT05564104
- Testing
- Cagrilintide
- Where
- 4 sites in Czechia, Germany and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.
- Trial name
- NCT06388616
- Testing
- Balcinrenone
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Human Immunodeficiency Virus (HIV) Infection
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with…
- Trial name
- NCT04515641
- Testing
- Islatravir
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Neoplasms
Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor
Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic impairment (Group 2, n = 8) according to the…
- Trial name
- NCT03521037
- Testing
- Rucaparib camsylate
- Where
- 6 sites in Poland, Slovakia and 1 more
- Volunteers
- 16 people
- Sponsor
- pharmaand GmbH
Hepatitis B Virus
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe…
- Trial name
- NCT02296853
- Testing
- TAF
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Solid Tumors, Hepatic Impairment
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function.
- Trial name
- NCT01443481
- Testing
- Dovitinib
- Where
- 12 sites in United States, Belgium and 4 more
- Volunteers
- 38 people
- Sponsor
- Novartis Pharmaceuticals
Hepatic Insufficiency
A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-3543-023)
The purpose of this study is to learn what happens to bomedemstat (MK-3543) in a person's body over time. Researchers will compare what happens to bomedemstat in the body when it is given to participants with mild or moderate…
- Trial name
- NCT07049939
- Testing
- Bomedemstat
- Where
- 3 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes Mellitus, Type 2
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment.
- Trial name
- NCT00437606
- Testing
- GK Activator (2), Ethanol
- Where
- 3 sites in Germany, Slovakia
- Volunteers
- 2 people
- Sponsor
- Hoffmann-La Roche
Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic…
- Trial name
- NCT07358546
- Testing
- Efimosfermin alfa
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline