Clinical trials: Hepatic Impairment (HI)
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.
Hepatic Impairment
Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls
The primary purpose of this study is to assess the pharmacokinetics (PK) of BPN14770 after a single oral administration of BPN14770 in participants with mild, moderate, and severe liver impairment compared with control…
- Trial name
- NCT07018492
- Testing
- BPN14770
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shionogi
Impaired Hepatic Function
Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
This clinical research trial is testing the investigational medicinal product (IMP) petrelintide that is being developed for body weight reduction in people living with obesity or overweight who have comorbidities.
- Trial name
- NCT07682818
- Testing
- Petrelintide
- Where
- 3 sites in Poland, Slovakia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Healthy Volunteer, Hepatic Impairment (HI)
A Varegacestat Hepatic Impairment Study
This clinical trial is designed to determine the pharmacokinetics, safety and tolerability of varegacestat in people with impaired liver function compared to people with normal liver function.
- Trial name
- NCT06841315
- Testing
- varegacestat
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Hepatic Impairment (HI)
A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)
The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control…
- Trial name
- NCT06442436
- Testing
- Nemtabrutinib
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Primary Biliary Cholangitis, Compensated Cirrhosis
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- Trial name
- NCT04950764
- Testing
- Seladelpar
- Where
- 20 sites in United States, South Korea and 2 more
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Hepatic Insufficiency
A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function
The purpose of this study is to measure the effect of HI on the PK, safety, and tolerability of a single dose of mavorixafor compared to matched healthy volunteers (HVs) with normal hepatic function.
- Trial name
- NCT06858696
- Testing
- Mavorixafor
- Where
- 4 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- X4 Pharmaceuticals
Hepatic Impairment
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled…
- Trial name
- NCT05753592
- Testing
- Part 1; LOU064 (Remibrutinib), Part 2; LOU064 (Remibrutinib)
- Where
- Hungary
- Volunteers
- 38 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
Healthy Adult Participants, Hepatic Impairment (HI)
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.
- Trial name
- NCT07715149
- Testing
- D-2570
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Hepatic Impairment, Moderate Hepatic Impairment
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.
- Trial name
- NCT06962332
- Testing
- Zanzalintinib
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Exelixis
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Hepatic Impairment (HI)
A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of liver function impairment versus participants with normal liver…
- Trial name
- NCT07324616
- Testing
- EDG-7500
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Advanced Malignancies and Hepatic Impairment
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver…
- Trial name
- NCT07422610
- Testing
- pelabresib
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers, Hepatic Impairment of Moderate Child Pugh Category
HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic…
- Trial name
- NCT04252417
- Testing
- MD1003
- Where
- 3 sites in France, Hungary
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA