Clinical trials: Impairment
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
Renal Impairment
Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects
This will be an open label study to assess the influence of renal impairment on the pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of 100 mg GLPG0634 for 10 days in subjects with renal…
- Trial name
- NCT02084199
- Testing
- GLPG0634
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Neurocognitive Disorders, Mild, Cognitive Impairment, Mild
Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders
This study aims to observe the effects of daily personalized digital reminiscence sessions, conducted with the help of a digital conversational agent, and to determine whether these sessions lead to improvements in symptoms such…
- Conditions
- Neurocognitive Disorders, Mild, Cognitive Impairment, Mild, Depression Mild, Apathy
- Trial name
- NCT07237009
- Where
- 5 sites in France
- Volunteers
- 80 people
- Sponsor
- KompanionCare SAS
Cognitive Dysfunction, Alzheimer's Disease
A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities
The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to…
- Trial name
- EVOLVE (NCT03639987)
- Testing
- Aducanumab
- Where
- 22 sites in United States
- Volunteers
- 52 people
- Sponsor
- Biogen
Hepatic Impairment, Healthy
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
- Trial name
- NCT02571816
- Testing
- ASP2215
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Alzheimer's Disease
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
- Trial name
- MINDSET 1 (NCT06976216)
- Testing
- KarXT, KarX-EC
- Where
- 119 sites in United States, Argentina and 17 more
- Volunteers
- 586 people
- Sponsor
- Bristol-Myers Squibb
Renal Impairment
A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal…
- Trial name
- NCT07741604
- Testing
- RO7795081
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment, Healthy Volunteers
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
The study is divided into two parts - Part A and Part B. Cagrilintide in combination with semaglutide, is under development for weight management.
- Trial name
- NCT05564104
- Testing
- Cagrilintide
- Where
- 4 sites in Czechia, Germany and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Impairment, Cannabis Intoxication
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.
- Trial name
- NCT04799093
- Testing
- EyeBOX
- Where
- United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Oculogica, Inc.
Diabetic Macular Edema
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
- Trial name
- GLIMMER (NCT04603937)
- Testing
- KSI-301, Aflibercept
- Where
- 72 sites in United States, Czechia and 6 more
- Volunteers
- 459 people
- Sponsor
- Kodiak Sciences Inc
Schizophrenia
Huperzine for Cognitive and Functional Impairment in Schizophrenia
Huperzine is a natural plant product with procognitive properties in patients with Alzheimer's disease. Cognitive difficulties hamper functioning in schizophrenia as well.
- Trial name
- NCT00963846
- Testing
- huperzine 0.2 mg BID, huperzine 0.4 mg BID, huperzine 0.8 mg BID
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Biomedisyn Corporation
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Visual Acuity, Geographic Atrophy
Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual…
- Conditions
- Visual Acuity, Geographic Atrophy, Macular Degeneration
- Trial name
- NCT02895815
- Testing
- CNTO 2476 (6.0 * 10^4 cells), CNTO 2476 (3.0 * 10^5 cells)
- Sponsor
- Janssen Pharmaceutical K.K.
Idiopathic Thrombocytopenic Purpura
Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura
- Trial name
- NCT05220878
- Testing
- GNR-069, Nplate
- Where
- 18 sites in Russia
- Volunteers
- 160 people
- Sponsor
- AO GENERIUM
Hepatic Impairment
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT04552808
- Testing
- Yimitasvir Phosphate
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK…
- Trial name
- HI (NCT02891408)
- Testing
- Firsocostat, Fenofibrate
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV Infections, Hepatic Impairment
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having…
- Trial name
- NCT00162097
- Testing
- efavirenz containing antiretroviral regimen
- Where
- 4 sites in United States, Italy
- Volunteers
- 21 people
- Sponsor
- Bristol-Myers Squibb
Congestive Heart Failure, Renal Impairment
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.
- Trial name
- NCT00652782
- Testing
- rolofyline
- Volunteers
- 160 people
- Sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Hepatic Function Abnormal
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with…
- Trial name
- NCT05283915
- Testing
- tolebrutinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sanofi
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