Clinical trials: Hepatic
Hepatic Impairment, Healthy Volunteers
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961
- Trial name
- NCT04604496
- Testing
- PF-06882961 20MG
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Tepotinib Hepatic Impairment Trial
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
- Trial name
- NCT03546608
- Testing
- Tepotinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, 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
Hepatitis C
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)
This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of…
- Trial name
- NCT01390428
- Testing
- Grazoprevir
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic…
- Trial name
- NCT04887064
- Testing
- Sotorasib
- Where
- 5 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatic Insufficiency
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to…
- Trial name
- NCT01512693
- Testing
- MK-0822
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Uterine Fibroids
Pharmacokinetics and Hepatic Safety of EGCG
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
- Trial name
- NCT04177693
- Testing
- Epigallocatechin gallate (EGCG), Clomiphene Citrate, Letrozole
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Yale University
Obesity, Type 2 Diabetes Mellitus
Effects of Obesity Treatments on Food Preferences and Metabolism
Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike.
- Trial name
- FPS (NCT01724060)
- Where
- 2 sites in United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Cholestasis, Primary Sclerosing Cholangitis
Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.
- Conditions
- Cholestasis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- NCT01879735
- Testing
- 11C-CSar, ICG
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Oncology
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate)…
- Trial name
- NCT02521376
- Testing
- Entospletinib
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Drug Induced Liver Injury
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver.
- Trial name
- Non-Drinker (NCT00616018)
- Testing
- acetaminophen
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kennon Heard
Hepatic Insufficiency, Renal Insufficiency
Study of Copanlisib in Hepatic or Renal Impairment
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
- Trial name
- NCT03172884
- Testing
- Copanlisib (ALIQOPA, BAY80-6946)
- Where
- 2 sites in Germany, Romania
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Polycystic Ovarian Syndrome, Obesity
Post-Prandial Liver Glucose Metabolism in PCOS
The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Trial name
- PLUM (NCT03041129)
- Testing
- oral glucose tolerance test, MRI of liver
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Solid Tumors
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
- Trial name
- NCT02063230
- Testing
- Selumetinib 50mg, Selumetinib 25mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted…
- Trial name
- NCT05005312
- Testing
- PF-07321332, Ritonavir
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Liver Diseases
Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to see how effective the investigators' optimized magnetic resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to enhance MRS as a diagnostic tool in non-alcohol…
- Trial name
- NAFLD (NCT00940537)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine