Clinical trials: Hepatic Impairment
Healthy, Hepatic Insufficiency
A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment [Child-Turcotte-Pugh (CTP) classification A and B] over different dose regimes of BI 685509…
- Trial name
- NCT03842761
- Testing
- BI 685509
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Boehringer Ingelheim
Moderate Hepatic Impairment
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
The primary purpose of this study is to compare the pharmacokinetics (PK) of a single oral dose of mitapivat in participants with moderate hepatic impairment to that in matched healthy control participants with normal hepatic…
- Trial name
- NCT05610657
- Testing
- Mitapivat
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Renal Impairment, Hepatic Impairment
Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment
The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.
- Trial name
- NCT02367872
- Testing
- TAK-272
- Where
- 4 sites in Japan
- Volunteers
- 48 people
- Sponsor
- Takeda
Hepatic Insufficiency, Liver Diseases
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
- Conditions
- Hepatic Insufficiency, Liver Diseases, Pharmacokinetics, Drug Metabolism
- Trial name
- NCT07102095
- Testing
- Sevabertinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment…
- Trial name
- NCT06004934
- Testing
- Avacopan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Multiple Myeloma
A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
The goal of the clinical trial is to collect safety data and information on how the body processes BVd in people with multiple myeloma (MM) who have moderate liver problems, compared with similar participants who have normal…
- Trial name
- NCT07609706
- Testing
- Belantamab mafodotin, Bortezomib, Dexamethasone
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
HIV, AIDS
TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) after a single dose and after repeated administration of…
- Conditions
- HIV, AIDS, Hepatic Impairment
- Trial name
- NCT00736905
- Testing
- TMC278
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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 Impairment
Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of mitiperstat.
- Trial name
- NCT05751759
- Testing
- Mitiperstat
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Hepatic Impairment
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite
This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy…
- Trial name
- NCT04190654
- Testing
- KW-6356
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin, Inc.
Hepatic Impairment, Healthy
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
- Trial name
- NCT02471274
- Testing
- sotagliflozin
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
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, Cirrhosis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Conditions
- Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
- Trial name
- NCT05045482
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zydus Therapeutics Inc.
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
Healthy
A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function
This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose.
- Trial name
- NCT07519135
- Testing
- PF-08653944
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Insufficiency
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal…
- Trial name
- NCT01836185
- Testing
- Evacetrapib
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment, Healthy
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
- Trial name
- NCT02571816
- Testing
- ASP2215
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic; Functional Disturbance
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
- Trial name
- NCT01392807
- Testing
- NKTR-118
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Chronic Kidney Disease, Hepatic Impairment
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time.
- Trial name
- NCT06402721
- Testing
- BAY3283142
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer