Clinical trials: Participants With Moderate Hepatic Impairment
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Human Immunodeficiency Virus (HIV) Infection
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with…
- Trial name
- NCT04515641
- Testing
- Islatravir
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants, Hepatic Impairment
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Trial name
- NCT07751250
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Prevention of Thromboembolic Events, Atrial Fibrillation
A Study to Learn How the Study Treatment Asundexian Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body in Participants With Mild or Moderate Reduction of Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to prevent the formation of blood clots in people who have or have had: an irregular and often rapid heartbeat a blocked blood flow to the heart a blocked or reduced blood flow to a part…
- Conditions
- Prevention of Thromboembolic Events, Atrial Fibrillation, Acute Myocardial Infarction, Non-cardioembolic Ischemic Stroke
- Trial name
- NCT05419635
- Testing
- Asundexian (BAY2433334)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Cystic Fibrosis
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.
- Trial name
- NCT05437120
- Testing
- VX-121/TEZ/D-IVA
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Primary Central Nervous System Lymphoma (PCNSL)
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
A study to investigate the pharmacokinetics of tirabrutinib in participants with mild, moderate, and severe hepatic impairment compared to healthy participants
- Trial name
- NCT07198087
- Testing
- Tirabrutinib
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic…
- Trial name
- NCT05935033
- Testing
- Emraclidine
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- AbbVie
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
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment…
- Trial name
- NCT06004934
- Testing
- Avacopan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
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.
Healthy, Hepatic Insufficiency
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy…
- Trial name
- NCT07165002
- Testing
- LY3537031
- Where
- 3 sites in Hungary, New Zealand and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Amnestic Mild Cognitive Impairment, Alzheimer's Disease
An Open-Label Study Investigating MK-8931 in Participants With Mild and Moderate Hepatic Insufficiency (MK-8931-016)
This study consists of Part I and an optional Part II. The purpose of Part I is to compare the plasma pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of 40 mg MK-8931 to participants with…
- Conditions
- Amnestic Mild Cognitive Impairment, Alzheimer's Disease, Prodromal Alzheimer's Disease
- Trial name
- NCT02910739
- Testing
- MK-8931
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Failure
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
- Trial name
- NCT04587622
- Testing
- Icenticaftor
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
- Trial name
- NCT05409911
- Testing
- S-217622
- Where
- 4 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Shionogi
Prostate Cancer
A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and…
- Trial name
- NCT02001571
- Testing
- Abiraterone acetate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cougar Biotechnology, Inc.
Liver Diseases
A Research Study on Etavopivat in Participants With and Without Liver Disease
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls).
- Trial name
- NCT06336018
- Testing
- Etavopivat
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Liver Dysfunction, Healthy
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild…
- Trial name
- NCT06916078
- Testing
- Lepodisiran
- Where
- 4 sites in United States, Hungary
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy…
- Trial name
- NCT05386589
- Testing
- Molnupiravir
- Where
- 3 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants, Participants With Mild Hepatic Impairment
A Phase I Clinical Trial to Evaluate the Pharmacokinetic and Safety of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Mild Hepatic Impairment, Moderate Hepatic Impairment, and Normal Liver Function
Use these resources to provide understandable information about this study to patients, families, and health care providers:This study is a multi-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical…
- Conditions
- Healthy Participants, Participants With Mild Hepatic Impairment, Participants With Moderate Hepatic Impairment
- Trial name
- NCT07694843
- Testing
- ammoxetine hydrochloride enteric-coated tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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