Clinical trials: Moderate Hepatic Impairment
Hepatic Impairment, Moderate Impaired Hepatic Function
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
Quizartinib is a novel oral Class III receptor tyrosine kinase (RTK) inhibitor exhibiting highly potent and selective but reversible inhibition of Feline McDonough sarcoma (FMS)-like tyrosine kinase 3 (FLT3).
- Trial name
- NCT04473664
- Testing
- Quizartinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Hepatic Insufficiency, Antibacterial Agents
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy…
- Trial name
- NCT03295266
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to…
- Trial name
- NCT01512693
- Testing
- MK-0822
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
Hepatic Impairment
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy…
- Trial name
- NCT05386589
- Testing
- Molnupiravir
- Where
- 3 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Moderate Hepatic Impairment
Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.
- Trial name
- NCT04223635
- Testing
- Pexidartinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Liver Diseases, Healthy
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched…
- Trial name
- NCT01298063
- Testing
- Afatinib
- Where
- Germany
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Ovarian Neoplasms, Neoplasms
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment…
- Conditions
- Ovarian Neoplasms, Neoplasms, Solid Tumor, Hepatic Impairment
- Trial name
- NCT03359850
- Testing
- Niraparib
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Tesaro, Inc.
Healthy Volunteer
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched…
- Trial name
- NCT01197911
- Testing
- aleglitazar
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
COVID-19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06568861
- Testing
- ALG-097558
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Hepatic Impairment
A Hepatic Impairment Study for PF-04965842.
This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.
- Trial name
- NCT03626415
- Testing
- PF-04965842
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.
- Trial name
- NCT01565902
- Testing
- BAF312
- Where
- 3 sites in Hungary, Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Infection, Human Immunodeficiency Virus
Fosamprenavir in Pts With Hepatic Impairment
APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic…
- Trial name
- NCT01054586
- Testing
- Intervention A Standard dose, Intervention B Reduced Dose, Intervention C
- Volunteers
- 167 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment…
- Trial name
- NCT02397707
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects
- Trial name
- NCT01621633
- Testing
- LCZ696
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals