Clinical trials: Hepatic Impairment
Advanced Solid Tumor, Hepatic Impairment
Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment
Lurbinectedin is mainly eliminated by the liver. Thus, Hepatic Impairment (HI) may alter the plasma concentrations of lurbinectedin.
- Trial name
- NCT05101265
- Testing
- Lurbinectedin
- Where
- 6 sites in Spain
- Volunteers
- 24 people
- Sponsor
- PharmaMar
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
Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Chinese Patients With Hepatic Impairment
Objective： To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for Injection in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment…
- Trial name
- NCT07906171
- Testing
- Levornidazole Disodium Phosphate for Injection
- Where
- 3 sites in China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
Moderate Hepatic Impairment, Healthy
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the…
- Trial name
- NCT04534699
- Testing
- KBP-5074
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
Hepatic Impairment
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function
The purpose of this study is to evaluate the pharmacokinetics (PK) of AL-335, odalasvir (ODV) and its metabolites ALS-022399 and ALS-022227, after a single oral dose of ODV and AL-335 respectively, in participants with moderately…
- Trial name
- NCT03277755
- Testing
- AL-335 800 mg, ODV 25 mg, SMV 75 mg
- Volunteers
- healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
- Trial name
- NCT03627754
- Testing
- Glasdegib 100 mg single oral dose
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Leukemia, Myeloid, Chronic
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
- Trial name
- NCT00759837
- Testing
- Bosutinib
- Where
- Poland
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Volunteers, Hepatic Impairment
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function.
- Trial name
- NCT03983161
- Testing
- Fedratinib
- Where
- 3 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Celgene
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment
This study is designed to determine the effects of a single dose of the study medication in subjects with and without hepatic impairment.
- Trial name
- NCT00768209
- Testing
- Phentermine and Topiramate
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Hepatic Impairment
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
- Trial name
- NCT01727128
- Testing
- BKM120
- Where
- 3 sites in Bulgaria, Germany and 1 more
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Pharmacokinetics, Healthy Subjects
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects
The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Conditions
- Pharmacokinetics, Healthy Subjects, Mild and Moderate Hepatic Impairment
- Trial name
- NCT01579461
- Testing
- mirabegron
- Where
- Slovakia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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
Hepatitis C, Chronic
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120…
- Trial name
- NCT01830127
- Testing
- Ribavirin, BI 207127 high dose, Faldaprevir
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
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
Advanced Malignancies
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
- Trial name
- NCT04831944
- Testing
- parsaclisib
- Where
- 5 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Hepatic Impairment
Study of Danicopan in Participants With Hepatic Impairment
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to healthy matched participants.
- Trial name
- NCT03555539
- Testing
- Danicopan
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Neoplasm Malignant
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Primary Objectives: To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment To determine the pharmacokinetics (PKs) of…
- Trial name
- NCT01140607
- Testing
- Cabazitaxel (XRP6258)
- Where
- 14 sites in United States
- Volunteers
- 56 people
- Sponsor
- Sanofi
Hepatic Impairment
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic…
- Trial name
- NCT03290443
- Testing
- Enasidenib
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Celgene
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
Parkinson's Disease
Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment
The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.
- Trial name
- NCT02101190
- Testing
- BIA 9-1067
- Where
- 3 sites in France, Russia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.