Clinical trials: Healthy, Hepatic Insufficiency
PK of FG-4592, Hepatic Insufficiency
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects.
- Conditions
- PK of FG-4592, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT02161224
- Testing
- FG-4592
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment
This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic…
- Trial name
- NCT07550634
- Testing
- MDR-001
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- MindRank AI Ltd
Hepatic Insufficiency, Healthy
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
- Trial name
- NCT03306667
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Hepatic Insufficiency
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
- Trial name
- NCT00781430
- Testing
- Neratinib (HKI-272)
- Where
- Russia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.
Healthy Volunteer Study, Hepatic Impairment
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Conditions
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- Trial name
- NCT06911320
- Testing
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, 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
Healthy, Hepatic Insufficiency
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants.
- Trial name
- NCT06190691
- Testing
- Pirtobrutinib
- Where
- 8 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Insufficiency
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal…
- Trial name
- NCT01860326
- Testing
- Alisporivir
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
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
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Insufficiency, Healthy Subjects
Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in…
- Trial name
- NCT04993404
- Testing
- Jaktinib Hydrochloride Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Hepatic Insufficiency
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.
- Trial name
- NCT03341884
- Testing
- Ipatasertib
- Where
- 3 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Hepatic Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01767103
- Testing
- Ferriprox®
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Healthy, Hepatic Insufficiency
A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function
The purpose of the study is to determine the concentration of canagliflozin in blood and urine samples after the administration of canagliflozin to study participants with mild or moderate hepatic (liver) impairment compared with…
- Trial name
- NCT01186588
- Testing
- Canagliflozin
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hepatic Insufficiency
Pharmacokinetics and Pharmacodynamics of BI 1356 in Subjects With Different Degrees of Liver Impairment as Compared to Healthy Subjects
To investigate the influence of mild, moderate, and severe liver impairment on the pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with normal hepatic function after single or multiple oral…
- Trial name
- NCT02183376
- Testing
- BI 1356
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Hepatic Insufficiency
Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetic effects of indacaterol in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT00416702
- Testing
- QAB149
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Novartis
Hepatic Insufficiency, Renal Insufficiency
Study of Copanlisib in Hepatic or Renal Impairment
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
- Trial name
- NCT03172884
- Testing
- Copanlisib (ALIQOPA, BAY80-6946)
- Where
- 2 sites in Germany, Romania
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
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