Clinical trials: Hepatic Impairment
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Liver Disease
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
- Trial name
- NCT01370148
- Testing
- conivaptan hydrochloride
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Oncology
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate)…
- Trial name
- NCT02521376
- Testing
- Entospletinib
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Esophageal Cancer, Advanced Solid Tumor
Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT05048368
- Testing
- Larotinib
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Blood Pressure, Oxidative Stress
Influence of Microfiltered-seawater Supplementation and Variable Resistance Training in Blood Pressure, Oxidative Stress, Hepatic, and Renal Biomarkers in Older Women
This study was conducted to investigate the effects of the intake of deep sea water prior to resistance training on blood pressure, oxidative stress and hepatic and renal variables in older women.
- Conditions
- Blood Pressure, Oxidative Stress, Renal Disease, Hepatic Impairment
- Trial name
- NCT06600243
- Testing
- Resistance training + deep sea water, Control + deep sea water
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- University of Valencia
Hepatic Insufficiency, Renal Insufficiency
Study of Copanlisib in Hepatic or Renal Impairment
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
- Trial name
- NCT03172884
- Testing
- Copanlisib (ALIQOPA, BAY80-6946)
- Where
- 2 sites in Germany, Romania
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.
- Trial name
- NCT00819468
- Testing
- Teduglutide
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shire
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
A Study of JNJ-53718678 in Participants With Hepatic Impairment
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with…
- Trial name
- NCT04332523
- Testing
- JNJ-53718678
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Severe Hepatic Impairment
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143
Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet the full study eligibility criteria will be enrolled into the study.
- Trial name
- NCT05199610
- Testing
- aumolertinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- EQRx International, Inc.
Hepatic Impairment, Pharmacokinetics
Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.
- Trial name
- NCT05856513
- Testing
- ZSP1273
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
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.
In Development for Cystic Fibrosis
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.
- Trial name
- NCT01208285
- Testing
- VX-770
- Where
- 3 sites in Czechia, Slovakia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
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
Hepatic Impairment
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05707390
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment
A Safety Study of Tucatinib in Healthy and Hepatically-Impaired Subjects
The investigators are doing this study to find out if tucatinib is safe for patients with liver problems. This study will look at participants with mild, moderate, and severe liver problems.
- Trial name
- NCT03722823
- Testing
- Tucatinib
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Seagen Inc.
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.
Solid Tumors
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
- Trial name
- NCT02063230
- Testing
- Selumetinib 50mg, Selumetinib 25mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Surufatinib Hepatic Impairment Study
An open-label, multicenter, single-dose, single-period, sequential study to determine the effect of hepatic impairment on the PK of surufatinib.
- Trial name
- NCT04755075
- Testing
- Surufatinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited