Clinical trials: Moderate Hepatic Impairment
Hepatic Impairment
Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT05517226
- Testing
- Cotadutide
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infection, Human Immunodeficiency Virus
Fosamprenavir in Pts With Hepatic Impairment
APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic…
- Trial name
- NCT01054586
- Testing
- Intervention A Standard dose, Intervention B Reduced Dose, Intervention C
- Volunteers
- 167 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment
The purpose of this study is: 1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2.
- Trial name
- NCT01319279
- Testing
- Hydrocodone bitartrate extended-release tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cephalon
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
- Trial name
- NCT07152288
- Testing
- HSK39297 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with…
- Conditions
- Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancers
- Trial name
- NCT06682988
- Testing
- Mirvetuximab Soravtansine
- Where
- 52 sites in United States, Australia and 6 more
- Volunteers
- 110 people
- Sponsor
- AbbVie
Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
- Trial name
- NCT01571388
- Testing
- dacomitinib
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Liver Dysfunction, Healthy Volunteers
An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage
The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.
- Trial name
- NCT03890809
- Testing
- BMS-986165
- Where
- 4 sites in Czechia, Hungary and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational…
- Trial name
- NCT01916993
- Testing
- NBI-98854 50 mg capsule
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Gaucher Disease
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects…
- Trial name
- NCT02536911
- Testing
- eliglustat
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched…
- Trial name
- NCT07783308
- Testing
- AZD4144
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca