Clinical trials: Hepatic Impairment
Healthy Subjects, Hepatic Impairment
The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of selatogrel (ACT-246475).
- Trial name
- NCT04406896
- Testing
- Selatogrel
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viatris Innovation GmbH
Thrombosis
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects
- Trial name
- NCT02982707
- Testing
- BMS-986177
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Liver Failure
Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with moderate hepatic impairment (Child Pugh score 7 9)…
- Trial name
- NCT02318836
- Testing
- Lofexidine Hydrochloride (HCl) tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
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
Healthy Volunteers, Hepatic Impairment
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control…
- Trial name
- NCT05814926
- Testing
- GP681
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Hepatic Impairment, Solid Tumor
Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment
This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of hepatic function, from normal to severely impaired.
- Conditions
- Hepatic Impairment, Solid Tumor, Cancer
- Trial name
- NCT02150733
- Testing
- Tivantinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Daiichi Sankyo
Autism Spectrum Disorder
The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan
This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared…
- Trial name
- NCT03912350
- Testing
- Balovaptan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
Pharmacokinetics and Safety of Rupatadine in Participants With Hepatic Impairment Compared to Control Participants.
The purpose of this study is to assess the PK and safety of rupatadine (10 mg) and its active metabolites in participants with mild, moderate, or severe hepatic impairment compared to matched control participants with normal…
- Trial name
- NCT06736340
- Testing
- Rupatadine
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Noucor Health S.A.
Hepatic Insufficiency
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
- Trial name
- NCT00859053
- Testing
- BMS-790052
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
The primary purpose of this study is to evaluate the plasma PK of JMKX003142 following a single dose in participants with mild and moderate hepatic impairment compared to matched healthy participants with normal hepatic function.
- Trial name
- NCT07909070
- Testing
- JMKX003142
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jemincare
Healthy Adults, Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001
This is a phase 1, open-label, non-randomized, parallel-group, single-dose study to assess the effect of hepatic impairment (assessed by the criteria of the Child-Pugh scale) on the pharmacokinetics (PK) and safety of KP-001 in…
- Trial name
- NCT06619054
- Testing
- KP-001
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Kaken Pharmaceutical
Hepatic Insufficiency
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
- Trial name
- NCT00692341
- Testing
- AG-013736
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
IDH1-Mutated Malignancies
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI).
- Trial name
- NCT07006688
- Testing
- Ivosidenib Oral Tablet
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Servier Bio-Innovation LLC
Hepatic Impairment
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
- Trial name
- NCT05078580
- Testing
- Iptacopan
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
Hepatic Impairment
A Safety Study of Tucatinib in Healthy and Hepatically-Impaired Subjects
The investigators are doing this study to find out if tucatinib is safe for patients with liver problems. This study will look at participants with mild, moderate, and severe liver problems.
- Trial name
- NCT03722823
- Testing
- Tucatinib
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Seagen Inc.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HSK39297 in subjects with mild to moderate hepatic impairment and normal hepatic function
- Trial name
- NCT07152288
- Testing
- HSK39297 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Severe Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic…
- Trial name
- NCT02170220
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Pulmonary Disease, Chronic Obstructive
A Study to Assess the Effects of GSK573719/VI Combination and GSK573719 Monotherapy in Subjects With Moderate Hepatic Impairment and Matched Healthy Volunteers
This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol combination in healthy subjects and subjects with moderate hepatic impairment.
- Trial name
- NCT01577680
- Testing
- Inhaled GSK573719/vilanterol, Inhaled GSK573719
- Where
- 2 sites in Hungary, Slovakia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline