Clinical trials: Hepatic Impairment
Hepatic Impairment
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted…
- Trial name
- NCT05391724
- Testing
- CMX001
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Hepatic Impairment
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.
- Trial name
- NCT02624557
- Testing
- Alpelisib
- Where
- 4 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Liver Dysfunction
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX.
- Trial name
- NCT01367522
- Testing
- SC Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
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
Radiprodil in Participants With Hepatic Impairment
This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants.
- Trial name
- NCT07457229
- Testing
- Radiprodil
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GRIN Therapeutics, Inc.
Hepatic Insufficiency, Renal Insufficiency
A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations
The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.
- Conditions
- Hepatic Insufficiency, Renal Insufficiency, Elderly
- Trial name
- NCT07345689
- Testing
- Anaprazole Sodium enteric-coated tablet
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Diabetes, Diabetes Mellitus, Type 2
Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT01507389
- Testing
- liraglutide
- Where
- Poland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy, Hepatic Insufficiency
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05916560
- Testing
- LY3437943
- Where
- 5 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Asthma
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single…
- Trial name
- NCT00419237
- Testing
- GW685698X
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject
This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment
- Trial name
- NCT05684653
- Testing
- Orelabrutinib Tablets
- Where
- 4 sites in China
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Healthy, Hepatic Impairment
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with…
- Trial name
- NCT07486102
- Testing
- BI 3000202
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Obesity, Overweight
A Pharmacokinetic Study of VCT220 in Particicants With Hepatic Injury and Normal Hepatic Function
This is an open-label, non-randomized study to assess how VCT220 is absorbed, distributed, metabolized, and eliminated after a single oral dose.
- Trial name
- NCT06938529
- Testing
- VCT220
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vincentage Pharma Co., Ltd
Diabetes
Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment
This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.
- Trial name
- NCT07193147
- Testing
- GZR4
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Hepatic Impairment, Healthy Participants
An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
The purpose of this study is to investigate SHR3680 in participants with different levels of liver function
- Trial name
- NCT04631549
- Testing
- SHR3680
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib
- Trial name
- NCT00418626
- Testing
- Nilotinib
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Mild Hepatic Imparement
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
This study is designed to assess the safety, tolerability and pharmacokinetics of ABI-6250 in participants with mild hepatic impairment compared with participants with normal hepatic function.
- Trial name
- NCT07850999
- Testing
- ABI-6250
- Where
- New Zealand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Hepatic Impairment, Pharmacokinetics
Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.
- Trial name
- NCT05856513
- Testing
- ZSP1273
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Moderate Hepatic Impairment
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in healthy participants and in patients with moderate…
- Trial name
- NCT01012284
- Testing
- TMC207
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tibotec BVBA
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched…
- Trial name
- NCT07783308
- Testing
- AZD4144
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca