Clinical trials: Moderate Hepatic Impairment
Hepatic Impairment
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic…
- Trial name
- NCT03290443
- Testing
- Enasidenib
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Celgene
Moderate Hepatic Impairment, Severe Hepatic Impairment
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Healthy Volunteers
- Trial name
- NCT05224609
- Testing
- Lorlatinib
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Purpura, Thrombocytopaenic, Idiopathic
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems.
- Trial name
- NCT00359463
- Testing
- eltrombopag
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Hepatic Impairment
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to…
- Trial name
- NCT03282513
- Testing
- AG-120 (Ivosidenib)
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- NCT07546760
- Testing
- AZD6234, AZD9550
- Where
- 4 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Pharmacokinetics of TD-4208 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
- NCT02581592
- Testing
- TD-4208
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Hepatic Insufficiency
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
- Trial name
- NCT04867941
- Testing
- ACP-196
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
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 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
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
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.
- Trial name
- NCT05376839
- Testing
- Cedirogant
- Where
- 3 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AbbVie
Hepatic Impairment, Healthy Volunteers
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
- Trial name
- NCT06352528
- Testing
- Repotrectinib
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Advanced Melanoma and Normal or Impaired, Hepatic Function
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with…
- Trial name
- NCT00543205
- Testing
- Genasense® (G3139, oblimersen sodium)
- Volunteers
- 6 people
- Sponsor
- Genta Incorporated
Hepatic Insufficiency, Liver Diseases
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
- Conditions
- Hepatic Insufficiency, Liver Diseases, Pharmacokinetics, Drug Metabolism
- Trial name
- NCT07102095
- Testing
- Sevabertinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects
- Trial name
- NCT01529294
- Testing
- Iloperidone
- Where
- 4 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca