Clinical trials: Moderate Hepatic Impairment
Hepatic Insufficiency, Neoplasms
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
- Trial name
- NCT05209295
- Testing
- Onureg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 2 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment
Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of hepatic impairment to healthy subjects.
- Trial name
- NCT01594957
- Testing
- LCQ908
- Where
- 2 sites in United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
Small Cell Lung Carcinoma
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
The purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics (PK), safety, and tolerability of JDQ443 in participants with varying degrees of hepatic impairment.
- Trial name
- NCT05329623
- Testing
- JDQ443
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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.
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.
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, Healthy
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy…
- Trial name
- NCT06908954
- Testing
- Palovarotene
- Where
- 4 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Ipsen
Advanced or Metastatic Solid Tumor, Liver Failure
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
- Trial name
- NCT04617522
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 15 sites in United States, France and 2 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Hepatic Insufficiency, Antibacterial Agents
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy…
- Trial name
- NCT03295266
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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 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
Healthy Volunteer
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe…
- Trial name
- NCT01185873
- Testing
- danoprevir, ritonavir
- Where
- 5 sites in United States, Czechia and 1 more
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Trial name
- NCT06052566
- Testing
- Efinopegdutide
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Symptomatic Neurogenic Orthostatic Hypertension, nOH
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal…
- Trial name
- NCT04200573
- Testing
- Ampreloxetine
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
HIV, AIDS
TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) after a single dose and after repeated administration of…
- Conditions
- HIV, AIDS, Hepatic Impairment
- Trial name
- NCT00736905
- Testing
- TMC278
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Atherosclerosis
Study to Evaluate Darapladib in Moderately Hepatically Impaired Subjects
The purpose of this study is to determine any differences in pharmacokinetic parameters of darapladib when dosed to people with moderate liver disease as compared to when dosed in normal healthy volunteers.
- Trial name
- NCT01154114
- Testing
- darapladib
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Schizophrenia, Hepatic Impairment
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate release (IR) paliperidone, after oral administration, in patients having moderate hepatic impairment compared to patients having normal…
- Trial name
- NCT00791284
- Testing
- Intermediate release (IR) Paliperidone
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.