Clinical trials: Liver Functions
Hepatic Impairment, Normal Hepatic Function
A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in both participants with varying stages of hepatic impairment and healthy participants.
- Trial name
- NCT02611505
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Population
Exploration of Gender Differences in Liver Aging
The liver is an important metabolic organ in the body. It participates in central metabolic activities to maintain systemic homeostasis. It is also one of the most vulnerable organs in the process of individual aging.
- Trial name
- NCT06591897
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Hepatic Cirrhosis
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
- Trial name
- NCT00856713
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Norgine
Chronic Liver Disease
Delta Radiomics for Liver Function Evaluation
To evaluate the feasibility and efficacy of delta radiomics-derived index based on Gd-EOB-DTPA enhanced MRI as a new imaging biomarker for the quantitative assessment of liver function.
- Trial name
- NCT05296434
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Zhujiang Hospital
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
GVHD, Bone Marrow Transplant Failure
α1-antitrypsin (AAT) Levels and Functions in Allogeneic Bone Marrow Transplantation and Throughout Progression Into GVHD
Create a personalized time and context curve of patient circulating α1-antitrypsin (AAT) levels and functions before hematopoietic stem cell transplantation and throughout progression into GVHD. PRIMARY ENDPOINT 1.
- Conditions
- GVHD, Bone Marrow Transplant Failure, Alpha 1-Antitrypsin
- Trial name
- AATGVHD-MARK (NCT03188601)
- Where
- 4 sites in Israel
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Hepatic Impairment
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted…
- Trial name
- NCT05005312
- Testing
- PF-07321332, Ritonavir
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Clinical Pharmacology
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight
BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease.
- Trial name
- NCT04366622
- Testing
- Riociguat (Adempas, BAY 63-2521)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatitis C Virus
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
- Trial name
- NCT02002767
- Testing
- Velpatasvir
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Obesity
Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly
The purpose of this study is to determine the effect of weight loss and exercise on liver and muscle fat.
- Trial name
- NCT00779207
- Testing
- weight loss and exercise, weight loss
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Liver Diseases, Hepatic Impairment
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
The purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants.
- Trial name
- NCT05857644
- Testing
- PF-07923568
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-alcoholic Fatty Liver Disease (NAFLD), Weight Loss
Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults
Non-alcoholic fatty liver disease (NAFLD) is defined by presence of hepatic steatosis (fat accumulation in liver cells), either by imaging or by biopsy and absence of causes for secondary hepatic fat accumulation such as…
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD), Weight Loss, Non-alcoholic Steatohepatitis (NASH)
- Trial name
- CGH-LiNASH (NCT02654665)
- Testing
- Lifestyle modification, Liraglutide
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Changi General Hospital
Amenorrhea
Determination of the Lowest, Safe and Effective Dose of Proellex
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
- Trial name
- NCT01187043
- Testing
- Proellex
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Diabetes Mellitus, Type 2
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants.
- Trial name
- NCT01767688
- Testing
- MK-3102
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Alpha-1 Antitrypsin Deficiency, AAT Deficiency
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability to work.
- Conditions
- Alpha-1 Antitrypsin Deficiency, AAT Deficiency, AATD, Cystic Fibrosis (CF)
- Trial name
- NCT01851642
- Testing
- History and physical exam., Blood draw., Pulmonary function testing.
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- University of Florida
Chronic Hepatitis C
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
- Trial name
- NCT01817985
- Testing
- GS-5816
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment, Healthy Volunteers
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function
A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function.
- Conditions
- Hepatic Impairment, Healthy Volunteers, Pharmacokinetics, Amount of R406 in Blood
- Trial name
- NCT01222455
- Testing
- Fostamatinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05517525
- Testing
- Brensocatib
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
- Trial name
- NCT04859426
- Testing
- DBPR108 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.