Clinical trials: Impairment
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Renal Insufficiency
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal…
- Trial name
- NCT01715259
- Testing
- Abiraterone acetate: participants with end-stage renal disease, Abiraterone acetate: matched control participants with normal renal function
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Advanced Solid Tumors
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.
- Trial name
- NCT02301117
- Testing
- TAS-102
- Where
- 14 sites in United States, Czechia and 1 more
- Volunteers
- 43 people
- Sponsor
- Taiho Oncology, Inc.
Branch Retinal Vein Occlusion
601 Versus Ranibizumab in Patients With Branch Retinal Vein Occlusion (BRVO)
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to BRVO
- Trial name
- NCT04667897
- Testing
- 601 1.25mg, Ranibizuman 0.5 mg
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Mild Cognitive Impairment, Alzheimer Disease
Safety and Immunogenicity of Repeated Doses of ABvac40 in Patients With a-MCI or Vm-AD
Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide.
- Trial name
- NCT03461276
- Testing
- ABvac40
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 134 people
- Sponsor
- Araclon Biotech S.L.
Neuromyelitis Optica Spectrum Disorder
Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder
The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.
- Trial name
- aNiMatO (NCT06374264)
- Testing
- MR-C-014
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedRhythms, Inc.
Stroke
A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke
This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic…
- Trial name
- NCT02928393
- Testing
- Basmisanil
- Where
- 13 sites in France, Spain
- Volunteers
- 5 people
- Sponsor
- Hoffmann-La Roche
Mild Cognitive Impairment
Exploratory Trial in Healthy Adults With Mild Cognitive Impairment,16-week Intervention With Mitocholine™
To evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment.
- Trial name
- NCT05690724
- Where
- Ireland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mitocholine Ltd
Renal Impairment
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
- Trial name
- NCT01740362
- Testing
- CP-690,550
- Where
- 4 sites in United States
- Volunteers
- 24 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
Renal Impairment
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment
Determine the influence of renal impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
- Trial name
- NCT02244762
- Testing
- 20 mg HC-ER
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Zogenix, Inc.
Cognitive Impairment
Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects
This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose…
- Trial name
- NCT01903824
- Testing
- CEP-26401, donepezil hydrochloride, modafinil
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
- Trial name
- NCT01571388
- Testing
- dacomitinib
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hearing Impairment
Clinical Evaluation of the Nuance Audio Hearing Aid in Adults With Mild to Moderate Hearing Difficulties
The research will produce clinical effectiveness performance metrics using standardised procedures of the Nuance Audio hearing device.
- Trial name
- NCT07100522
- Testing
- Hearing aid in spectacle frame form factor, hearing aid
- Where
- Australia
- Volunteers
- 21 people
- Sponsor
- Luxottica Group S.p.A.
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment, Hepatic Function
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal…
- Trial name
- NCT02421042
- Testing
- Lenvatinib
- Where
- 5 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Alzheimer Disease, Cognitive Impairment
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium…
- Trial name
- NCT01453569
- Testing
- Sodium oligo-mannurarate 600mg, Sodium oligo-mannurarate 900mg
- Where
- 24 sites in China
- Volunteers
- 255 people
- Sponsor
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
Alzheimer Disease, Dementia
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD).
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Disorders, Cognitive Decline
- Trial name
- ADKIT (NCT07294586)
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Amoneta Diagnostics SAS
Sleep
Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment
Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment
- Trial name
- NCT06267586
- Testing
- PeptiSleep
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nuritas Ltd
Alzheimer Disease, Mild Cognitive Impairment
Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey
There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia, Cognitive Decline
- Trial name
- QUIP II (NCT06025877)
- Testing
- PrecivityAD2(TM) blood test
- Where
- 9 sites in United States
- Volunteers
- 400 people
- Sponsor
- C2N Diagnostics
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