Clinical trials: Hepatic Impairment
Type2 Diabetes Mellitus
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg.
- Trial name
- NCT03557658
- Testing
- Bexagliflozin
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theracos
Hepatic Impairment
Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic…
- Trial name
- NCT02245243
- Testing
- Delafloxacin
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Melinta Therapeutics, Inc.
Hepatic Impairment
Study of Single-dose DS-3201b in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.
- Trial name
- NCT04276662
- Testing
- DS-3201b
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Hepatic Function Abnormal
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of…
- Trial name
- NCT05607173
- Testing
- Fexinidazole (HOE239)
- Where
- 2 sites in Bulgaria, France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanofi
Secondary Hypogonadism
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- Trial name
- NCT01923870
- Testing
- Androxal 25 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Hepatic Insufficiency
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function.
- Trial name
- NCT00969813
- Testing
- CP-690,550
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment
To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin pharmacokinetics and their metabolites following administration of CPX-351.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02269579
- Testing
- CPX-351
- Where
- 5 sites in United States
- Sponsor
- Jazz Pharmaceuticals
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Hepatic Insufficiency, Liver Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.
- Trial name
- NCT07853040
- Testing
- INCB161734
- Volunteers
- 24 people
- Sponsor
- Incyte Corporation
Myelofibrosis
To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the…
- Trial name
- NCT07480824
- Testing
- TQ05105
- Where
- 2 sites in China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatic Impairment, Healthy Volunteers
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
This is a multicenter, open-label study to assess the PK of a single 1-mg oral dose of CC-220 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function.
- Trial name
- NCT03824678
- Testing
- CC-220
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celgene
Severe Hepatic Impairment, Normal Hepatic Function
A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men
The influence of severely diminished liver function on the metabolism, safety, and tolerability of a single oral dose of enzalutamide in a group of 8 men.
- Trial name
- NCT02138162
- Testing
- enzalutamide
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Hepatic Impairment
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
- Trial name
- NCT04469920
- Testing
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
- Where
- 2 sites in United States
- Volunteers
- 98 people
- Sponsor
- Zydus Therapeutics Inc.
NSCLC (advanced Non-small Cell Lung Cancer)
Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages.
- Trial name
- NCT06823258
- Testing
- HS-10365
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Digestive System Disorders
Evaluation of the Pharmacokinetics of Ulimorelin in Subjects With Hepatic Impairment and Healthy Subjects
Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a single intravenous (IV) dose in order to identify potential patients at risks in terms of severity of hepatic dysfunction and to…
- Trial name
- NCT01405599
- Testing
- Ulimorelin
- Where
- Slovakia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Norgine
Phenylketonuria
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have…
- Trial name
- NCT07713758
- Testing
- Repinatrabit
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hepatic Impairment, Healthy
Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function
The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of…
- Trial name
- NCT05765344
- Testing
- Bulevirtide
- Where
- 6 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Insufficiency
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study.
- Trial name
- NCT04097704
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Celgene
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
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