Clinical trials: Impaired Hepatic Function
Hepatic Impairment
Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.
- Trial name
- NCT00819468
- Testing
- Teduglutide
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shire
Renal Insufficiency, Kidney Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624710
- Testing
- INCB054707
- Where
- 4 sites in United States, Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Impaired Hepatic Function, Healthy
Study of ALXN2050 in Participants With Hepatic Impairment
This study will investigate the impact of impaired hepatic function (IHF) on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with varying degrees of IHF.
- Trial name
- NCT05259085
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Liver Diseases
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: stable loss of liver function with mild or moderate severity none of…
- Trial name
- NCT06340347
- Testing
- Osivelotor
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pfizer
Hepatic Insufficiency
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic…
- Trial name
- NCT04226833
- Testing
- entrectinib
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a…
- Trial name
- NCT05582187
- Testing
- Fosmanogepix
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
- Trial name
- NCT04859426
- Testing
- DBPR108 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Hepatic Impairment
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
- Trial name
- NCT01429337
- Testing
- Midostaurin
- Where
- 7 sites in United States, Belgium and 4 more
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment, Healthy
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
- Trial name
- NCT02471274
- Testing
- sotagliflozin
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Sever Aplastic Anaemia
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as…
- Trial name
- NCT05088642
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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
Worsening Chronic Heart Failure, Diabetic Nephropathy
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic…
- Trial name
- NCT04881994
- Testing
- Finerenone (BAY94-8862)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
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
Pharmacokinetics and Safety of Rupatadine in Participants With Hepatic Impairment Compared to Control Participants.
The purpose of this study is to assess the PK and safety of rupatadine (10 mg) and its active metabolites in participants with mild, moderate, or severe hepatic impairment compared to matched control participants with normal…
- Trial name
- NCT06736340
- Testing
- Rupatadine
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Noucor Health S.A.
Pharmacokinetics, Hepatic Impairment
MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function. The main questions it aims to answer are: Do people with abnormal liver function experience greater absorption of MDMA? Does…
- Trial name
- NCT03606538
- Testing
- Midomafetamine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Resilient Pharmaceuticals
Autism Spectrum Disorder
The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan
This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared…
- Trial name
- NCT03912350
- Testing
- Balovaptan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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
Complement Mediated Primary or Secondary Glomerular Diseases
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06674915
- Testing
- HRS-5965 capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.