Clinical trials: Impaired Hepatic Function
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
Diabetes, Healthy
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects…
- Trial name
- NCT00976326
- Testing
- insulin degludec
- Where
- Slovakia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05517525
- Testing
- Brensocatib
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
Esophageal Cancer, Advanced Solid Tumor
Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT05048368
- Testing
- Larotinib
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatic Impairment, Healthy, Hepatic Insufficiency
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease
The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.
- Conditions
- Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy Adults
- Trial name
- NCT07677358
- Testing
- Atirmociclib
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Insufficiency, Healthy Subjects
Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in…
- Trial name
- NCT04993404
- Testing
- Jaktinib Hydrochloride Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT04552808
- Testing
- Yimitasvir Phosphate
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatic Impairment, Healthy Volunteers
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function
A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function.
- Conditions
- Hepatic Impairment, Healthy Volunteers, Pharmacokinetics, Amount of R406 in Blood
- Trial name
- NCT01222455
- Testing
- Fostamatinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Multiple Myeloma
A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in Relapsed/Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in…
- Trial name
- DREAMM 13 (NCT04398680)
- Testing
- Belantamab mafodotin
- Where
- 18 sites in United States, Greece and 1 more
- Sponsor
- GlaxoSmithKline
PK of FG-4592, Hepatic Insufficiency
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects.
- Conditions
- PK of FG-4592, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT02161224
- Testing
- FG-4592
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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
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.
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Pharmacokinetics
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control…
- Trial name
- NCT06562946
- Testing
- Pimicotinib
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
- Trial name
- NCT03627754
- Testing
- Glasdegib 100 mg single oral dose
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Function Abnormal
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of…
- Trial name
- NCT05607173
- Testing
- Fexinidazole (HOE239)
- Where
- 2 sites in Bulgaria, France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Impairment
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT07428525
- Testing
- AMG 133
- Where
- 5 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
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