Clinical trials: Hepatic Impairment
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
Hepatic Impairment
Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers.
- Trial name
- HI (NCT01134185)
- Testing
- prucalopride
- Where
- Russia
- Volunteers
- 24 people
- Sponsor
- Movetis
Hepatic Impairment
Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline
The purpose of this study is to test whether mild liver impairment affects blood levels of istradefylline in humans. Decreased liver function could possibly increase istradefylline levels.
- Trial name
- NCT02256033
- Testing
- Istradefylline
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Hepatic Function Abnormal
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with…
- Trial name
- NCT05283915
- Testing
- tolebrutinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sanofi
Hepatic Impairment
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT07428525
- Testing
- AMG 133
- Where
- 5 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Hepatic Impairment, Healthy Volunteers
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function
A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function.
- Conditions
- Hepatic Impairment, Healthy Volunteers, Pharmacokinetics, Amount of R406 in Blood
- Trial name
- NCT01222455
- Testing
- Fostamatinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Pharmacokinetics, Hepatic Insufficiency
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
- Conditions
- Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency
- Trial name
- NCT02894385
- Testing
- BAY1841788
- Where
- 2 sites in Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment
The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.
- Trial name
- NCT00828932
- Testing
- Lorcaserin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatic Impairment
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
This study was to investigate the pharmacokinetic (PK) and safety of M2951 (Bruton's tyrosine kinase [BTK] inhibitor) in participants with different degrees of hepatic impairment compared to participants with normal hepatic…
- Trial name
- NCT04546789
- Testing
- M2951 (BTK inhibitor)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Pain
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers.
- Trial name
- NCT00373243
- Testing
- GW406381
- Where
- 2 sites in Hungary
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Overweight, Obesity
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function
The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people…
- Trial name
- NCT07587710
- Testing
- NNC0487-0111
- Where
- 2 sites in Slovakia
- Volunteers
- 35 people
- Sponsor
- Novo Nordisk A/S
Small Cell Lung Carcinoma
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
The purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics (PK), safety, and tolerability of JDQ443 in participants with varying degrees of hepatic impairment.
- Trial name
- NCT05329623
- Testing
- JDQ443
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment, Healthy
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).
- Trial name
- NCT06048302
- Testing
- Obicetrapib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- NewAmsterdam Pharma
Hepatic Impairment, Healthy, Hepatic Insufficiency
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease
The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.
- Conditions
- Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy Adults
- Trial name
- NCT07677358
- Testing
- Atirmociclib
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment, Hepatic Impairment
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild…
- Trial name
- NCT05731804
- Testing
- SIM0417 600 mg; Ritonavir100 mg, SIM0417 375 mg; Ritonavir100 mg, SIM0417 750 mg; Ritonavir100 mg
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Hepatic Impairment
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Hepatic impairment PK study
- Trial name
- NCT03309202
- Testing
- PF-05221304
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer
A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with…
- Trial name
- NCT01714154
- Testing
- danoprevir, ritonavir, setrobuvir
- Where
- 3 sites in Hungary, Poland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche