Clinical trials: Hepatic Function Abnormal
Hepatic Impairment
A Study of RAY1225 in Participants With Impaired Liver Function
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.
- Trial name
- NCT06577415
- Testing
- RAY1225
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
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.
Malignant Melanoma
Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction
The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics).
- Trial name
- NCT00145041
- Testing
- Vincristine Sulfate Liposomes Injection
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Acrotech Biopharma Inc.
Solid Tumor, Adult, Impaired Liver Function
Oral Docetaxel in Patients With Normal or Impaired Liver Function
This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a…
- Trial name
- NCT05084456
- Testing
- ModraDoc006/r
- Where
- Netherlands
- Sponsor
- Modra Pharmaceuticals
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.
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Liver Dysfunction
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX.
- Trial name
- NCT01367522
- Testing
- SC Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
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
Hepatitis b & Liver Dysfunction
Study on PK of Hydronidone in Patients and Special Population
1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction). 2.
- Trial name
- NCT04123769
- Testing
- Hydronidone
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Tumors
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction
Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of…
- Trial name
- NCT00113113
- Testing
- Rubitecan
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Hepatic Function Abnormal
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of…
- Trial name
- NCT05607173
- Testing
- Fexinidazole (HOE239)
- Where
- 2 sites in Bulgaria, France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Healthy, Hepatic Insufficiency
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants.
- Trial name
- NCT06190691
- Testing
- Pirtobrutinib
- Where
- 8 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Type 2 Diabetes Mellitus, Liver Dysfunction
Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)
This clinical trial is designed to assess the effect of hepatic impairment on the pharmacokinetic and pharmacodynamic of glufast tablets 10 mg.
- Trial name
- NCT04349696
- Testing
- Mitiglinide
- Where
- 2 sites in Taiwan
- Volunteers
- 16 people
- Sponsor
- Orient Europharma Co., Ltd.
Diabetes, Healthy
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects…
- Trial name
- NCT00976326
- Testing
- insulin degludec
- Where
- Slovakia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
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
Mild Hepatic Dysfunction, Moderate Hepatic Dysfunction
Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction
This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules. An adaptive 2-stage study design will be implemented.
- Trial name
- NCT01358565
- Testing
- Fx-1006A
- Where
- South Africa
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Carcinoma, Hepatocellular
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment
- Trial name
- NCT00437424
- Testing
- Brivanib
- Where
- 5 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb
Cholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid…
- Conditions
- Cholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency, LAL-Deficiency
- Trial name
- NCT01488097
- Testing
- sebelipase alfa
- Where
- 10 sites in United States, Canada and 3 more
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.