Clinical trials: Hepatic Impairment
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic impairment.
- Trial name
- NCT01767948
- Testing
- PCI-32765
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Janssen Research & Development, LLC
Insomnia
A Study to Evaluate the Pharmacokinetics of LY2624803 in Subjects With Hepatic Impairment
The purpose of this study is to evaluate the impact of hepatic dysfunction on the pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276.
- Trial name
- NCT01257178
- Testing
- LY2624803
- Where
- 4 sites in Germany, Hungary and 1 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
NASH
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
- Trial name
- NCT03207425
- Testing
- EDP 305
- Where
- 3 sites in United States, Czechia and 1 more
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Healthy Participants, Gastrointestinal Neoplasms
A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib
This study evaluates the pharmacokinetics (PK), safety, and tolerability of velzatinib in participants with mild, moderate, and severe hepatic impairment (HI) and participants with normal hepatic function.
- Trial name
- NCT07859735
- Testing
- Velzatinib
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant
The primary objective of this multiple-dose, adaptive design study is to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of relacorilant relative to healthy matched control male and female subjects (Part 1).
- Trial name
- NCT06094725
- Testing
- Relacorilant
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
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.
Hepatic Insufficiency, Antibacterial Agents
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy…
- Trial name
- NCT03295266
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Amnestic Mild Cognitive Impairment, Alzheimer's Disease
An Open-Label Study Investigating MK-8931 in Participants With Mild and Moderate Hepatic Insufficiency (MK-8931-016)
This study consists of Part I and an optional Part II. The purpose of Part I is to compare the plasma pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of 40 mg MK-8931 to participants with…
- Conditions
- Amnestic Mild Cognitive Impairment, Alzheimer's Disease, Prodromal Alzheimer's Disease
- Trial name
- NCT02910739
- Testing
- MK-8931
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy…
- Trial name
- NCT04993157
- Testing
- FIA586
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Symptomatic Neurogenic Orthostatic Hypertension, nOH
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal…
- Trial name
- NCT04200573
- Testing
- Ampreloxetine
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Hepatic Impairment
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
- Trial name
- NCT04154774
- Testing
- Apalutamide
- Where
- 4 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers, Hepatic Insufficiency
A Single Dose Study of LY2605541 in Participants With Liver Impairment
The primary purpose of this study is to help answer the following research questions: To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those…
- Conditions
- Healthy Volunteers, Hepatic Insufficiency, Diabetes Mellitus, Type 2
- Trial name
- NCT01751399
- Testing
- LY2605541
- Where
- 2 sites in Germany, Hungary
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
Hepatic Impairment, Normal Hepatic Function
A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in both participants with varying stages of hepatic impairment and healthy participants.
- Trial name
- NCT02611505
- Testing
- Esketamine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment, Healthy
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
- Trial name
- NCT01888393
- Testing
- lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
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 Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.
- Trial name
- NCT03587363
- Testing
- Erdafitinib
- Where
- 2 sites in Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Healthy, Liver Diseases
Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with…
- Trial name
- NCT02171832
- Testing
- BI 1744 CL, low dose, BI 1744 CL, high dose
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim