Clinical trials: Impairment
Hepatic Insufficiency
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
- Trial name
- NCT00692341
- Testing
- AG-013736
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Cognitive Symptoms
Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment
The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory…
- Conditions
- Breast Cancer, Cognitive Symptoms, Memory Disorders
- Trial name
- NCT00387062
- Testing
- Computer-based Cognitive Training
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Posit Science Corporation
Hepatic Impairment
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.
- Trial name
- NCT03802786
- Testing
- Imeglimin
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Poxel SA
Mild Cognitive Impairment (MCI), Mild Alzheimer Disease
A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy…
- Trial name
- ADAPT-MCI-01 (NCT07174869)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Indivi AG
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.
Pain, Hepatic Impairment
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
Review differences between how a healthy person and how a person with liver problems handles the study drug.
- Trial name
- NCT00812305
- Testing
- SKY0402 300mg in healthy patients, SKY0402 300mg in hepatically impaired patients
- Where
- Poland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Heart Failure With Reduced Ejection Fraction (HFrEF), Renal Impairment
AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment
The present study is designed to test the effect of AZD3427 on renal perfusion in participants with heart failure and reduced eGFR (30 to 90 mL/min/1.73m2).
- Trial name
- Re-PERFUSE (NCT06611423)
- Testing
- AZD3427, Dopamine, Radiolabelled ligand
- Where
- Sweden
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study of LY2886721 in Healthy Participants
The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the…
- Trial name
- NCT01534273
- Testing
- LY2886721
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Mild Cognitive Impairment, Dementia
An Imaging Study to Investigate the Distribution of GSK239512 in the Brain.
GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain (receptor occupancy).
- Trial name
- NCT00474513
- Testing
- GSK239512
- Where
- Canada
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia
Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function
This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
- Trial name
- NCT07422857
- Testing
- [18F]-APN-1607
- Where
- 2 sites in China
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- JYAMS PET Research & Development Limited
Chronic Hepatic Impairment
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers.
- Trial name
- NCT01465412
- Testing
- Preladenant
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cognitive Impairment, End Stage Renal Disease
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.
- Trial name
- NCT04527328
- Testing
- AKST1210, Hemodialysis
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Alkahest, Inc.
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.
- Trial name
- NCT03587363
- Testing
- Erdafitinib
- Where
- 2 sites in Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy, Renal Insufficiency
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy…
- Trial name
- NCT05611957
- Testing
- LY3437943
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Renal Impairment
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
- Trial name
- NCT01367509
- Testing
- Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Type2 Diabetes
Type 2 Diabetes Patients With Renal Impairment
The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal…
- Trial name
- NCT04221399
- Testing
- DWP16001
- Volunteers
- 35 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Type 2 Diabetes
A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects
The purpose of this study is to assess how fast HRS9531 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
- NCT06246175
- Testing
- HRS9531
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Safety
Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease
The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with…
- Trial name
- NCT01309828
- Testing
- Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide
- Where
- 53 sites in Bulgaria, Germany and 6 more
- Volunteers
- 153 people
- Sponsor
- Takeda
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
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