Clinical trials: Hepatic Impairment
Epilepsy
An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit.
- Trial name
- NCT02281526
- Testing
- BIA 2-093
- Where
- South Africa
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Type 2 Diabetes Mellitus, Hepatic Impairment
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.
- Trial name
- NCT02115347
- Testing
- Ertugliflozin 15 mg
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Tumors
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.
- Trial name
- NCT02301104
- Testing
- TAS-102
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
Hepatic Insufficiency
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
- Trial name
- NCT04867941
- Testing
- ACP-196
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Hepatitis C, Hepatic Insufficiency
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
- Trial name
- NCT00314054
- Testing
- HCV-796
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatic Impairment
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with…
- Trial name
- NCT01027169
- Testing
- safinamide
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh…
- Trial name
- NCT06734208
- Testing
- Divarasib
- Where
- 4 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989
The purpose of the study is to evaluate the single-dose pharmacokinetic (PK) of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in participants with liver cirrhosis and various…
- Trial name
- NCT04208386
- Testing
- JNJ-73763989
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC
Sever Aplastic Anaemia
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as…
- Trial name
- NCT05088642
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatitis C, Chronic
Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic…
- Trial name
- NCT01919125
- Testing
- IDX719
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Hepatic Impairment, Healthy Participants
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and…
- Trial name
- NCT07025551
- Testing
- MK-8527
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment
The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.
- Trial name
- NCT03816631
- Testing
- Pimodivir
- Where
- 2 sites in Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV
Chronic Hepatic Impairment
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers.
- Trial name
- NCT01465412
- Testing
- Preladenant
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetes
A Trial of SP2086 With Hepatic Insufficiency
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Trial name
- NCT06035406
- Testing
- Retagliptin Phosphate Tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Insufficiency
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran etexilate.
- Trial name
- NCT02170571
- Testing
- Dabigatran etexilate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment, Healthy Adult Participants
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment).
- Trial name
- NCT07856004
- Testing
- Tacabrutideg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Hepatic Impairment, Healthy Participants
Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function
The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function
- Trial name
- NCT03962049
- Testing
- Linzagolix
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ObsEva SA
Infections, Bacterial
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe…
- Trial name
- NCT03562117
- Testing
- Gepotidacin
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Schizophrenia, Hepatic Impairment
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate release (IR) paliperidone, after oral administration, in patients having moderate hepatic impairment compared to patients having normal…
- Trial name
- NCT00791284
- Testing
- Intermediate release (IR) Paliperidone
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.