Clinical trials: Hepatic Impairment
Hepatic Impairment
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.
- Trial name
- udenafil (NCT00956306)
- Testing
- Udenafil
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Dong-A Pharmaceutical Co., Ltd.
Healthy Participants, Hepatic Impairment
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Trial name
- NCT07751250
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
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
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
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment
The purpose of this study is: 1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2.
- Trial name
- NCT01319279
- Testing
- Hydrocodone bitartrate extended-release tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cephalon
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
- Trial name
- NCT06952634
- Testing
- envudeucitinib
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Alumis Inc
Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506
Moderate Hepatic Impairment Study Phase This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase: Cohort A: Subjects with moderate hepatic impairment Cohort…
- Trial name
- HS-10506-114 (NCT07844967)
- Testing
- HS-10506
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
Healthy Volunteer
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched…
- Trial name
- NCT01197911
- Testing
- aleglitazar
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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 Impairment
Aleniglipron Hepatic Impairment Study
The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.
- Trial name
- NCT07872033
- Testing
- Aleniglipron
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Hepatic Insufficiency
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in…
- Trial name
- NCT02191865
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to…
- Trial name
- NCT03282513
- Testing
- AG-120 (Ivosidenib)
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Locally Advanced Solid Tumor, Metastatic Solid Tumor
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.
- Trial name
- NCT05828277
- Testing
- repotrectinib (TPX-0005)
- Where
- 2 sites in United States, Spain
- Sponsor
- Turning Point Therapeutics, Inc.
Neoplasms
A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer.
- Trial name
- NCT01767623
- Testing
- Vemurafenib
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant
This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment.
- Trial name
- NCT06928779
- Testing
- Dazucorilant
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe…
- Trial name
- NCT05790304
- Testing
- Camizestrant
- Where
- 4 sites in United States, Bulgaria and 1 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment, Healthy Participants
Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT06425198
- Testing
- BMS-986278
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb