Clinical trials: Hepatic Impairment
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Hepatic Insufficiency
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic…
- Trial name
- NCT04226833
- Testing
- entrectinib
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Insufficiency
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
- Trial name
- NCT00859053
- Testing
- BMS-790052
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose…
- Trial name
- NCT05706623
- Testing
- Apraglutide
- Where
- 2 sites in Germany, Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VectivBio AG
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954
The purpose of this study is to evaluate the effect of varying degrees of hepatic function on the single dose PK of IV TAK-954.
- Trial name
- NCT03277274
- Testing
- TAK-954
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Hepatic Impairment
Tepotinib Hepatic Impairment Trial
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
- Trial name
- NCT03546608
- Testing
- Tepotinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Moderate Hepatic Impairment
A Study of Belzutifan (MK-6482) in Participants With Hepatic Impairment (MK-6482-020)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched…
- Trial name
- NCT04995484
- Testing
- Belzutifan
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when…
- Trial name
- NCT02387814
- Testing
- Abemaciclib
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
Diabetes Mellitus, Type 2
A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment
The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition: To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying…
- Trial name
- NCT01253304
- Testing
- LY2189265
- Where
- 2 sites in Germany, Hungary
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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.
Healthy, Hepatic Insufficiency
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
- Trial name
- NCT02334800
- Testing
- Palbociclib 75 mg Capsule
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Type2 Diabetes Mellitus
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg.
- Trial name
- NCT03557658
- Testing
- Bexagliflozin
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theracos
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
HIV Infections, Hepatic Impairment
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having…
- Trial name
- NCT00162097
- Testing
- efavirenz containing antiretroviral regimen
- Where
- 4 sites in United States, Italy
- Volunteers
- 21 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with…
- Trial name
- NCT04056468
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
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)
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals