Clinical trials: Moderate Hepatic Impairment
Early Alzheimer's Disease
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
- Trial name
- NCT02859207
- Testing
- E2609
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
COVID-19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06568861
- Testing
- ALG-097558
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Healthy Participants
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100
- Trial name
- NCT05537142
- Testing
- BV100
- Where
- Hungary
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- BioVersys AG
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 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
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to…
- Trial name
- NCT03282513
- Testing
- AG-120 (Ivosidenib)
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
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.
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Insufficiency
Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment
The primary objectives were: To determine the effects of steady state TPV co-administered with low dose RTV on steady state PegIFN and RBV in HIV negative subjects with mild hepatic impairment (scheme A) To determine the effects…
- Trial name
- NCT02259855
- Testing
- Tipranavir, Ritonavir, Pegylated interferon
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Insufficiency
A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver.
- Trial name
- NCT07401862
- Testing
- LY3841136
- Where
- 3 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment, Healthy Participants
An Investigational Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
The purpose of this study is to investigate SHR6390 in participants with different levels of liver function
- Trial name
- NCT04631575
- Testing
- SHR6390
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Improved Glycemic Control in Patients With Type 2 Diabetes
A Trial of HR17031 Injection With Hepatic Insufficiency
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Trial name
- NCT05151705
- Testing
- HR17031 injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment…
- Trial name
- NCT02397707
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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.
Pharmacokinetic Differences, Y-3
Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects
The goal of this clinical trial is to assess the pharmacokinetic profiles and safety of Y-3 in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age…
- Conditions
- Pharmacokinetic Differences, Y-3, Saftey, Mild Hepatic Insufficiency
- Trial name
- NCT07055412
- Testing
- Y-3 for injection（40mg）
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurodawn Pharmaceutical Co., Ltd.
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
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
Moderate Hepatic Impairment, Healthy
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the…
- Trial name
- NCT04534699
- Testing
- KBP-5074
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
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