Clinical trials: Hepatic Impairment
Neoplasm Malignant
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Primary Objectives: To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment To determine the pharmacokinetics (PKs) of…
- Trial name
- NCT01140607
- Testing
- Cabazitaxel (XRP6258)
- Where
- 14 sites in United States
- Volunteers
- 56 people
- Sponsor
- Sanofi
Diabetes, Diabetes Mellitus, Type 2
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT02016911
- Testing
- semaglutide
- Where
- 6 sites in Czechia, Poland and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Impaired Hepatic Function
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States.
- Trial name
- NCT02135302
- Testing
- eravacycline
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Healthy, Hepatic Impairment
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects.
- Trial name
- NCT01493869
- Testing
- cabozantinib
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Exelixis
Hepatic Insufficiency
A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-3543-023)
The purpose of this study is to learn what happens to bomedemstat (MK-3543) in a person's body over time. Researchers will compare what happens to bomedemstat in the body when it is given to participants with mild or moderate…
- Trial name
- NCT07049939
- Testing
- Bomedemstat
- Where
- 3 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers
To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic impairment in comparison to healthy subjects
- Trial name
- NCT02265627
- Testing
- BIIL 284 BS
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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 Impairment
Radiprodil in Participants With Hepatic Impairment
This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants.
- Trial name
- NCT07457229
- Testing
- Radiprodil
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GRIN Therapeutics, 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
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.
Metastatic Cancer
Pharmacokinetic and Safety Study of Pixantrone in Patients With Metastatic Cancer and Hepatic Impairment
This study will be conducted in patients with metastatic cancer and either moderate, severe, or no hepatic impairment who have failed other antineoplastic therapies or for whom there is no standard therapy.
- Trial name
- Hepatic (NCT01632436)
- Testing
- Pixantrone
- Where
- United States
- Sponsor
- CTI BioPharma
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Hepatic Impairment
Fruquintinib Hepatic Impairment Study
An Open-label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib
- Trial name
- NCT05216367
- Testing
- Fruquintinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x…
- Trial name
- NCT03423446
- Testing
- Telotristat Ethyl
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Hepatic Insufficiency
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI).
- Trial name
- NCT05093972
- Testing
- Ulonivirine
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Hepatic impairment PK study
- Trial name
- NCT03309202
- Testing
- PF-05221304
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Participants Scheduled for Surgery Under Spinal Anesthesia Without Impairment of Renal, Hepatic, Cardiac or Respiratory Function
Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.
Spinal anaesthesia has the advantage that produced nerve block by the injection of local anaesthetic into cerebrospinal fluid (CSF).
- Trial name
- NCT04275375
- Testing
- observation study about the autonomic response after spinal anesthesia
- Where
- Taiwan
- Volunteers
- 46 people
- Sponsor
- National Central University
Hepatic Impairment
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
- Trial name
- NCT01727128
- Testing
- BKM120
- Where
- 3 sites in Bulgaria, Germany and 1 more
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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