Clinical trials: Impaired Hepatic Function
Renal Insufficiency, Hepatic Insufficiency
Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases
In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland.
- Conditions
- Renal Insufficiency, Hepatic Insufficiency, Immunosuppression
- Trial name
- RETRACE (NCT04170309)
- Testing
- Ceftobiprole medocaril
- Where
- 18 sites in France, Germany and 2 more
- Volunteers
- 428 people
- Sponsor
- Advanz Pharma
Advanced Melanoma and Normal or Impaired, Hepatic Function
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with…
- Trial name
- NCT00543205
- Testing
- Genasense® (G3139, oblimersen sodium)
- Volunteers
- 6 people
- Sponsor
- Genta Incorporated
Hepatic Impairment
KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
This is a study to characterize the pharmacokinetics, safety and tolerability of KD025 and KD025 metabolites in subjects with mild, moderate or severe hepatic impairment compared to healthy subjects with normal hepatic function.
- Trial name
- NCT04166942
- Testing
- KD025
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Asthma
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single…
- Trial name
- NCT00419237
- Testing
- GW685698X
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP…
- Trial name
- NCT07643155
- Testing
- Treprostinil Palmitil Inhalation Powder
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK…
- Trial name
- HI (NCT02891408)
- Testing
- Firsocostat, Fenofibrate
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer
Normal Hepatic Function, Impaired Hepatic Function
Effect of Hepatic Impairment on LDE225..
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- NCT01764776
- Testing
- LDE225
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
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
Alcohol Dependence
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
- Trial name
- NCT02197598
- Testing
- nalmefene
- Where
- 3 sites in Germany
- Volunteers
- 45 people
- Sponsor
- H. Lundbeck A/S
Healthy, Hepatic Insufficiency
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
- Trial name
- NCT02334800
- Testing
- Palbociclib 75 mg Capsule
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes
A Trial of SP2086 With Hepatic Insufficiency
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Trial name
- NCT06035406
- Testing
- Retagliptin Phosphate Tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Insufficiency
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function.
- Trial name
- NCT00969813
- Testing
- CP-690,550
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
COVID-19 Pneumonia
Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired liver function.
- Trial name
- NCT06106113
- Testing
- GST-HG171 Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
Hepatic Impairment, Healthy
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe…
- Trial name
- NCT01732263
- Testing
- SSP-004184
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Shire
Phenylketonuria
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have…
- Trial name
- NCT07713758
- Testing
- Repinatrabit
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Diabetes, Diabetes Mellitus, Type 2
Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT01507389
- Testing
- liraglutide
- Where
- Poland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Liver Disease, Hyponatremia
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
- Trial name
- NCT00851227
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Hepatic Impairment
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to…
- Trial name
- NCT03282513
- Testing
- AG-120 (Ivosidenib)
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.