Clinical trials: Impaired Hepatic Function
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- 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
Muscular Atrophy, Spinal
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy…
- Trial name
- NCT03920865
- Testing
- Risdiplam
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Anaemia
Daprodustat Hepatic Impairment Study
Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of anemia of chronic kidney disease (CKD).
- Trial name
- NCT03223337
- Testing
- Daprodustat (GSK1278863)
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Insufficiency, Hepatic Impairment
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood.
- Trial name
- NCT06575959
- Testing
- Enlicitide
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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.
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
Hepatic Insufficiency
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
- Trial name
- NCT00692341
- Testing
- AG-013736
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
Infections, Bacterial
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe…
- Trial name
- NCT03562117
- Testing
- Gepotidacin
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
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
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
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
Liver Diseases, Hepatic Impairment
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
The purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants.
- Trial name
- NCT05857644
- Testing
- PF-07923568
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Insufficiency
A Study of Tirzepatide in Participants With Impaired Liver Function
The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.
- Trial name
- NCT03940742
- Testing
- Tirzepatide
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment, Healthy Participants
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600.
- Trial name
- NCT04016077
- Testing
- PF-06651600 30 mg
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
This was a multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 in participants with chronic hepatic impairment relative to matched participants with normal hepatic…
- Trial name
- NCT06736223
- Testing
- ITF2357
- Where
- 3 sites in Bulgaria, France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Italfarmaco