Clinical trials: Patients With Impaired Hepatic Function
Advanced Solid Tumors, Hematologic Malignancies
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing…
- Trial name
- SPI-FOL-102 (NCT07036133)
- Testing
- Pralatrexate Injection
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Acrotech Biopharma Inc.
Liver Fibrosis
Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls
This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal…
- Trial name
- NCT07394309
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
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; Functional Disturbance
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
- Trial name
- NCT01392807
- Testing
- NKTR-118
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
HIV Infections, Hepatic Insufficiency
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.
- Trial name
- NCT00144248
- Testing
- nevirapine
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 51 people
- Sponsor
- Boehringer Ingelheim
Histologically-proven and Radiologically-confirmed Solid Tumors
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function
This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment.
- Trial name
- NCT01278849
- Testing
- ASA404
- Where
- 4 sites in Italy, New Zealand
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
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 Impairment
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
Primary Objective: To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban. Secondary Objective: To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic…
- Trial name
- NCT01126086
- Testing
- otamixaban XRP0673
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Sanofi
Advanced Solid Tumors
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment.
- Trial name
- NCT00139620
- Testing
- Tarceva, erlotinib, OSI-774
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- OSI Pharmaceuticals
Asthma
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single…
- Trial name
- NCT00419237
- Testing
- GW685698X
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
- Trial name
- NCT01429337
- Testing
- Midostaurin
- Where
- 7 sites in United States, Belgium and 4 more
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
- Trial name
- NCT04293029
- Testing
- SHR0302
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Impairment
EVP-6124 Hepatic Impairment Study
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT01984736
- Testing
- Experimental: EVP-6124
- Where
- 3 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- FORUM Pharmaceuticals Inc
Moderate Hepatic Impairment, Healthy
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the…
- Trial name
- NCT04534699
- Testing
- KBP-5074
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe…
- Trial name
- NCT01185873
- Testing
- danoprevir, ritonavir
- Where
- 5 sites in United States, Czechia and 1 more
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
The purpose of this study is to characterize the pharmacokinetics (what the body does to the study medication) of JNJ-38518168 at approximately steady-state (stable medication levels) after administration of multiple oral 30 mg…
- Trial name
- NCT01863784
- Testing
- JNJ-38518168
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
- Trial name
- NCT00432627
- Testing
- Deferasirox
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Patients With Impaired Hepatic Function
Pharmacokinetics Study in Patients With Impaired Hepatic Function
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
- Trial name
- NCT02586194
- Testing
- ASP015K
- Where
- 6 sites in Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc