Clinical trials: Hepatic Impairment
Chronic Hepatitis B Infections
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment…
- Trial name
- NCT07342868
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Aligos Therapeutics
Hepatic Impairment
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
- Trial name
- NCT02857868
- Testing
- ABL001
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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.
Obesity, Overweight, T2DM (Type 2 Diabetes Mellitus)
Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function
This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose.
- Trial name
- NCT07877038
- Testing
- DA-302168S
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Hepatic Impairment
Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects
To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.
- Trial name
- IPI-145-14 (NCT02095587)
- Testing
- IPI-145
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- SecuraBio
Hepatic Impairment (HI)
A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of liver function impairment versus participants with normal liver…
- Trial name
- NCT07324616
- Testing
- EDG-7500
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Hepatic Impairment
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose.
- Trial name
- NCT05599932
- Testing
- Siremadlin
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
- Trial name
- NCT02985632
- Testing
- BMS-986141
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.
- Trial name
- NCT04942964
- Testing
- Bocidelpar
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hypercholesterolemia
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
- Trial name
- NCT01670734
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- 2 sites in France, Moldova
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Insufficiency
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
- Trial name
- NCT00781430
- Testing
- Neratinib (HKI-272)
- Where
- Russia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.
Healthy, Hepatic Impairment
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects.
- Trial name
- NCT01493869
- Testing
- cabozantinib
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Exelixis
Hepatic Impairment
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.
- Trial name
- NCT03802786
- Testing
- Imeglimin
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Poxel SA
Hepatic Function Abnormal, Healthy Volunteers
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
- Trial name
- NCT06444204
- Testing
- Rilzabrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Principia Biopharma, a Sanofi Company
Hepatic Impairment
GT-032 Belapectin Hepatic Impairment
This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched…
- Trial name
- NCT04332432
- Testing
- belapectin
- Where
- 4 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Galectin Therapeutics Inc.
Hepatic Insufficiency
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.
- Trial name
- NCT03341884
- Testing
- Ipatasertib
- Where
- 3 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
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
Histologically-proven and Radiologically-confirmed Solid Tumors
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function
This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment.
- Trial name
- NCT01278849
- Testing
- ASA404
- Where
- 4 sites in Italy, New Zealand
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
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, Advanced Malignant Solid Tumor
A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function
This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe…
- Trial name
- NCT04241835
- Testing
- Tazemetostat
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 18 people
- Sponsor
- Epizyme, Inc.