Clinical trials: Hepatic Impairment
Hepatic Insufficiency
A Study of LY2140023 in Hepatically-Impaired Participants
This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).
- Trial name
- NCT01475136
- Testing
- LY2140023
- Where
- 2 sites in Germany, Hungary
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Denovo Biopharma LLC
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C
Open-Label Hepatic Impairment Study
This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion…
- Trial name
- NCT01497327
- Testing
- PSI-352938, PSI-7977
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Hepatic Insufficiency, Liver Diseases
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.
- Trial name
- NCT07559474
- Testing
- INCB123667
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
Hepatic Insufficiency
A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function
Evaluate simufilam levels in the blood of hepatically impaired individuals compared to Healthy individuals of similar demographics
- Trial name
- NCT06390410
- Testing
- Simufilam
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Cassava Sciences, Inc.
Chronic Hepatitis B Infections
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment…
- Trial name
- NCT07342868
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Aligos Therapeutics
Hepatic Impairment and Healthy Female
GS1-144 in Participants With Hepatic Impairment and Healthy Female
GS1-144 in Participants with Hepatic Impairment and Healthy Female
- Trial name
- NCT07491289
- Testing
- GS1-144 tablet
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
- Trial name
- NCT05919069
- Testing
- AZD2693
- Where
- 3 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Ultrasound Therapy, Hepatic Impairment
PVB Versus TAP in Hepatic Patients Undergoing Laparoscopic Cholecystectomy
The Era of using ultrasound guided blocks provides an attractive and more or less safe alternative to other techniques. Among these blocks is ultrasound-guided transverse abdominis plane block (USG-TAP block) that controls pain…
- Conditions
- Ultrasound Therapy, Hepatic Impairment, Laparoscopic Cholecystectomy
- Trial name
- NCT04208165
- Testing
- ultrasound-guided nerve block PVB, ultrasound-guided nerve block TAB
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Theodor Bilharz Research Institute
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, Renal Impairment
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
- Trial name
- NCT05112419
- Testing
- Zibotentan
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational…
- Trial name
- NCT01916993
- Testing
- NBI-98854 50 mg capsule
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
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
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 Insufficiency
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when…
- Trial name
- NCT02387814
- Testing
- Abemaciclib
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
- Trial name
- NCT02242734
- Testing
- 20 mg HC-ER
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zogenix, Inc.
Pharmacokinetics of MDV3100, Healthy Subjects
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects. The study will consist of two treatment arms.
- Conditions
- Pharmacokinetics of MDV3100, Healthy Subjects, Kidney Diseases
- Trial name
- NCT01901133
- Testing
- MDV3100
- Where
- Moldova
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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 Impairment, Cirrhosis
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of…
- Trial name
- NCT05484206
- Testing
- VIR-2218, VIR-3434
- Where
- 4 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.