Clinical trials: Hepatic Impairment
Hepatic Impairment
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects
- Trial name
- NCT01529294
- Testing
- Iloperidone
- Where
- 4 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Moderate Hepatic Impairment
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in healthy participants and in patients with moderate…
- Trial name
- NCT01012284
- Testing
- TMC207
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tibotec BVBA
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.
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
Hepatic Impairment
Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers.
- Trial name
- HI (NCT01134185)
- Testing
- prucalopride
- Where
- Russia
- Volunteers
- 24 people
- Sponsor
- Movetis
Essential Hypertension, Hepatic Impairment
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
- Trial name
- NCT01146938
- Testing
- fimasartan
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Hepatic Impairment, Healthy Volunteers
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function
A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function.
- Conditions
- Hepatic Impairment, Healthy Volunteers, Pharmacokinetics, Amount of R406 in Blood
- Trial name
- NCT01222455
- Testing
- Fostamatinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Impairment, Liver Transplantation
CNI-free "Bottom"-up Immunosuppression in Patients Undergoing Liver Transplantation
The primary objective of the trial is to evaluate efficacy and safety of delayed introduction (up to 30 days post-transplantation in patients without signs of acute rejection that had received an aIL-2 induction and MMF) of…
- Conditions
- Renal Impairment, Liver Transplantation, Everolimus
- Trial name
- BUILT_01 (NCT01023542)
- Testing
- delayed, low-dose CNI, BU-CNI, BU-Everolimus
- Where
- Germany
- Volunteers
- 45 people
- Sponsor
- University of Regensburg
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.
Hepatic Impairment
Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment
This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and…
- Trial name
- NCT00672581
- Testing
- ZD4054
- Where
- Czechia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
HIV Infections, Hepatic Impairment
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having…
- Trial name
- NCT00162097
- Testing
- efavirenz containing antiretroviral regimen
- Where
- 4 sites in United States, Italy
- Volunteers
- 21 people
- Sponsor
- Bristol-Myers Squibb
Pain, Hepatic Impairment
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
Review differences between how a healthy person and how a person with liver problems handles the study drug.
- Trial name
- NCT00812305
- Testing
- SKY0402 300mg in healthy patients, SKY0402 300mg in hepatically impaired patients
- Where
- Poland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
HIV, AIDS
TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) after a single dose and after repeated administration of…
- Conditions
- HIV, AIDS, Hepatic Impairment
- Trial name
- NCT00736905
- Testing
- TMC278
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatic Impairment
BG9928 in Subjects With Hepatic Impairment
The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic…
- Trial name
- NCT00858156
- Testing
- BG9928
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Biogen
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment
This study is designed to determine the effects of a single dose of the study medication in subjects with and without hepatic impairment.
- Trial name
- NCT00768209
- Testing
- Phentermine and Topiramate
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC