Clinical trials: Severe Hepatic Impairment
Hepatic Impairment
A Study to Assess Safety and Pharmacokinetics of Telaprevir in Patients With Hepatic Impairment
The purpose of this study is to determine whether the pharmacokinetic (what the body does to the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment, compared to the pharmacokinetic parameters…
- Trial name
- NCT01600976
- Testing
- telaprevir
- Where
- 2 sites in Czechia, Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Infectious Diseases BVBA
Hepatic Impairment
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
- Trial name
- NCT06952634
- Testing
- envudeucitinib
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Alumis Inc
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
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
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
Healthy, Hepatic Impairment
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study.
- Trial name
- NCT07023354
- Testing
- BI 1291583
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Liver Diseases
A Research Study on Etavopivat in Participants With and Without Liver Disease
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls).
- Trial name
- NCT06336018
- Testing
- Etavopivat
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic…
- Trial name
- NCT03902002
- Testing
- Omaveloxolone 50 mg capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biogen
Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- CAMPOLINA (NCT06812780)
- Testing
- AZD2389
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Non-alcoholic Fatty Liver Disease
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment.
- Trial name
- NCT03681457
- Testing
- LJN452
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Aleniglipron Hepatic Impairment Study
The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.
- Trial name
- NCT07872033
- Testing
- Aleniglipron
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Hepatic Impairment, Healthy Adult Participants
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment).
- Trial name
- NCT07856004
- Testing
- Tacabrutideg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational…
- Trial name
- NCT01916993
- Testing
- NBI-98854 50 mg capsule
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
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
Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment
This study is designed investigate the effect of severe hepatic impairment on the pharmacokinetics (PK) of cenobamate.
- Trial name
- NCT04791553
- Testing
- Cenobamate
- Where
- 2 sites in Poland, Slovakia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- SK Life Science, Inc.
Severe Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic…
- Trial name
- NCT02170220
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Hepatic Impairment
A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic…
- Trial name
- NCT03742882
- Testing
- CC-90001
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celgene
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Hepatic Impairment, Healthy Participants
Study to Assess Drug Levels and Safety of BMS-986278 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 BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT06425198
- Testing
- BMS-986278
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi