Clinical trials: Hepatic Impairment
Hepatic Impairment
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment
Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects…
- Trial name
- NCT01762462
- Testing
- SAR302503
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.
- Trial name
- NCT03397888
- Testing
- Betrixaban
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Hepatic Insufficiency
A Study of LY2140023 in Hepatically-Impaired Participants
This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).
- Trial name
- NCT01475136
- Testing
- LY2140023
- Where
- 2 sites in Germany, Hungary
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Denovo Biopharma LLC
Healthy Study Participants, Impaired Hepatic Function
A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
The purpose of the study is to evaluate the plasma pharmacokinetic (PK), safety and tolerability of padsevonil (PSL) in hepatically impaired and non-hepatically impaired study participants.
- Trial name
- NCT04136444
- Testing
- Padsevonil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Hepatic Impairment
Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Participants
The purpose of this study is to evaluate the effect of various degrees of hepatic impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155.
- Trial name
- NCT05490030
- Testing
- TNO155
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Liver Dysfunction
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age…
- Trial name
- NCT02604498
- Testing
- Nemonoxacin
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zhejiang Medicine Co., Ltd.
Hepatic Impairment
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically…
- Trial name
- NCT07144111
- Testing
- Inavolisib
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
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
Healthy Volunteer
A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment.
- Trial name
- NCT01356550
- Testing
- RO4917838
- Where
- 3 sites in France, Russia
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.
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
Diabetic Kidney Disease
Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.
- Trial name
- NCT02509624
- Testing
- Selonsertib
- Where
- 5 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
In Development for Cystic Fibrosis
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.
- Trial name
- NCT01208285
- Testing
- VX-770
- Where
- 3 sites in Czechia, Slovakia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Cystic Fibrosis
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.
- Trial name
- NCT05437120
- Testing
- VX-121/TEZ/D-IVA
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy Volunteer, Hepatic Impairment
Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
- Trial name
- NCT05724693
- Testing
- Bemnifosbuvir (BEM)
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Liver Insufficiency
Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment
To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function.
- Trial name
- NCT02120547
- Testing
- Cenicriviroc in mild liver impaired, Cenicriviroc in moderate liver impaired
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Tobira Therapeutics, Inc.
Hepatic Insufficiency
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems
This study is open to adults aged 18 years and older. People without liver problems and people who have mild or moderate liver problems can join the study.
- Trial name
- NCT05661344
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment, Healthy Participants
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600.
- Trial name
- NCT04016077
- Testing
- PF-06651600 30 mg
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer