Clinical trials: Impaired Hepatic Function
Liver Dysfunction, Liver Insufficiency
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
- Conditions
- Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure
- Trial name
- NCT03515980
- Testing
- BMS-986231
- Where
- 4 sites in Hungary, Poland
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Preeclampsia, Hypertension
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia
- Trial name
- NCT02780414
- Where
- 20 sites in United States
- Volunteers
- 1,730 people
- Sponsor
- Progenity, Inc.
Chronic Kidney Disease, Hepatic Impairment
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time.
- Trial name
- NCT06402721
- Testing
- BAY3283142
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Type 2 Diabetes Mellitus, Hepatic Impairment
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.
- Trial name
- NCT02115347
- Testing
- Ertugliflozin 15 mg
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Moderate Hepatic Impairment
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
The primary purpose of this study is to compare the pharmacokinetics (PK) of a single oral dose of mitapivat in participants with moderate hepatic impairment to that in matched healthy control participants with normal hepatic…
- Trial name
- NCT05610657
- Testing
- Mitapivat
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
HEPATITIS C (HCV)
Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations.
- Trial name
- NCT00651027
- Testing
- PF-868554
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
- Trial name
- NCT04154774
- Testing
- Apalutamide
- Where
- 4 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI)…
- Trial name
- NCT03369002
- Testing
- seladelpar
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Moderate Hepatic Impairment, Normal Hepatic Function
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
- Trial name
- NCT02871570
- Testing
- Rivipansel
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlycoMimetics Incorporated
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's lymphoma with or without impaired liver or kidney…
- Conditions
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma
- Trial name
- NCT00118170
- Testing
- sorafenib tosylate, pharmacological study
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Cancer Institute (NCI)
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.
Liver Dysfunction
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age…
- Trial name
- NCT02604498
- Testing
- Nemonoxacin
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zhejiang Medicine Co., Ltd.
Mild Cognitive Impairment, Mild Dementia
Resistance Training to Individuals for Cognitive Impairment With Dementia
This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function…
- Trial name
- TRAIN4BRAIN (NCT06185010)
- Testing
- One Resistance Training Set (Single Session), Three Resistance Training Sets (Single Session), One Resistance Training Set (8 Weeks)
- Where
- Portugal
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Beira Interior
Moderate Hepatic Impairment
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).
- Trial name
- NCT07343960
- Testing
- Capivasertib
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose…
- Trial name
- NCT05706623
- Testing
- Apraglutide
- Where
- 2 sites in Germany, Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VectivBio AG
Insulin Sensitivity, Multiple Mitochondrial Dysfunctions Syndrome
Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action
The purpose of this study is to examine the effect of the chronic treatment of type 2 diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and insulin signaling/action and (2) oral glucose tolerance…
- Trial name
- DAPA MITO (NCT01439854)
- Testing
- Dapagliflozin
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Depressive Disorder, Major
A Study of LY2216684 in Participants With Impaired Hepatic Function
The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it.
- Trial name
- NCT01241435
- Testing
- LY2216684
- Where
- 3 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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.