Clinical trials: Impairment
Primary Central Nervous System Lymphoma (PCNSL)
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
A study to investigate the pharmacokinetics of tirabrutinib in participants with mild, moderate, and severe hepatic impairment compared to healthy participants
- Trial name
- NCT07198087
- Testing
- Tirabrutinib
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Idiopathic Pulmonary Fibrosis
Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment
Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment…
- Trial name
- NCT02788474
- Testing
- nintedanib
- Where
- 86 sites in United States, Australia and 11 more
- Volunteers
- 347 people
- Sponsor
- Boehringer Ingelheim
Memory Disorders
Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.
- Trial name
- NCT00567060
- Testing
- Piracetam
- Volunteers
- 676 people
- Sponsor
- UCB Pharma
Renal Impairment
A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function
This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.
- Trial name
- NCT04446507
- Testing
- Saroglitazar magnesium
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Zydus Therapeutics Inc.
Hepatic Impairment
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
- Trial name
- NCT05409911
- Testing
- S-217622
- Where
- 4 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Shionogi
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice
This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied.
- Trial name
- FINEGUST (NCT05526157)
- Testing
- Finerenone (Kerendia, BAY 948862), Sodium-glucose cotransporter 2 inhibitors (SGLT2i), Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- Where
- 5 sites in United States, Denmark and 3 more
- Volunteers
- 50,000 people
- Sponsor
- Bayer
Hepatic Impairment
Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment
This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and…
- Trial name
- NCT00672581
- Testing
- ZD4054
- Where
- Czechia
- Volunteers
- 32 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.
Alzheimers Disease
Clinical Utility of Early vs. Late Blood Biomarker Testing for Alzheimer's Disease
The goal of this study is to evaluate whether use of the PrecivityAD2 blood biomarker assay with early result disclosure along with discretionary Precivity-ApoE proteotype testing will shorten the time to Alzheimer's Disease or…
- Trial name
- ADELAIDE (NCT06856681)
- Testing
- PrecivityAD2 - Early Testing, PrecivityAD2 - Delayed Testing
- Sponsor
- C2N Diagnostics
MDS, AML
Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function
The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations.
- Conditions
- MDS, AML, Solid Tumors, Multiple Myeloma
- Trial name
- RENAL (NCT00652626)
- Testing
- azacitidine
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Celgene
Renal Impairment
Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
- Trial name
- NCT05793450
- Testing
- IBI362
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Liver Diseases
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: stable loss of liver function with mild or moderate severity none of…
- Trial name
- NCT06340347
- Testing
- Osivelotor
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pfizer
Moderate Hepatic Impairment
Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.
- Trial name
- NCT04223635
- Testing
- Pexidartinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Aspergillosis, Invasive Fungal Infections
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal…
- Trial name
- VITAL (NCT00634049)
- Testing
- isavuconazole
- Where
- 96 sites in United States, Argentina and 17 more
- Volunteers
- 149 people
- Sponsor
- Astellas Pharma Inc
Renal Impairment
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal…
- Trial name
- NCT05386758
- Testing
- Molnupiravir
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Non-valvular Atrial Fibrillation (NVAF)
Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function
In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of…
- Trial name
- XARETO (NCT04356989)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Taiwan
- Volunteers
- 493 people
- Sponsor
- Bayer
Hepatic Impairment
A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic…
- Trial name
- NCT01631097
- Testing
- Tivozanib hydrochloride
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- AVEO Pharmaceuticals, Inc.
Mild Alzheimer's Disease, Mild Cognitive Impairment
Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
This is a safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease.
- Trial name
- NCT01482013
- Testing
- HPP854
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- High Point Pharmaceuticals, LLC.
Normal Hepatic Function, Impaired Hepatic Function
Effect of Hepatic Impairment on LDE225..
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- NCT01764776
- Testing
- LDE225
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Small Cell Lung Carcinoma
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
The purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics (PK), safety, and tolerability of JDQ443 in participants with varying degrees of hepatic impairment.
- Trial name
- NCT05329623
- Testing
- JDQ443
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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