Clinical trials: Impairment
Hepatic Impairment
A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)
The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants.
- Trial name
- NCT04676425
- Testing
- Elpipodect
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Mild Cognitive Impairment (MCI) Amnestic, Parkinson Disease (PD)
Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)
The study aims to phenotype hearing in patients with early stage of neurodegenerative disorders to explore the prevalence of various hearing disorders in comparison to a control population.
- Conditions
- Mild Cognitive Impairment (MCI) Amnestic, Parkinson Disease (PD), Healthy Participants
- Trial name
- SAPHIR (NCT07083089)
- Testing
- Thorough Hearing assessment
- Where
- 4 sites in France
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- Cilcare SAS
Parkinson Disease, Cognitive Dysfunction
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive…
- Trial name
- NCT04476017
- Testing
- SAGE-718
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease
The goal of this study is to learn if medical image analysis software, Neurophet SCALE PET, can enhance readers' amyloid beta positivity performance in people with Alzheimer's Disease.
- Trial name
- NCT07417540
- Testing
- Neurophet SCALE PET
- Where
- South Korea
- Volunteers
- 190 people
- Sponsor
- NEUROPHET
Patients With Impaired Renal Function
Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal Function
The objective of this study is to compare the pharmacokinetics of ASP015K in patients with impaired renal function and subjects with normal renal function.
- Trial name
- NCT02603497
- Testing
- ASP015K
- Where
- 2 sites in Japan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Attention Impairment
Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
- Trial name
- NCT00688376
- Testing
- Donepezil hydrochloride
- Where
- 31 sites in United States, Argentina and 8 more
- Volunteers
- 72 people
- Sponsor
- Eisai Inc.
Type 2 Diabetes Mellitus, Impaired Glucose Tolerance
Effects of Colesevelam HCl On Bile Acid Kinetics
This project will compare the amount of bile acids and their kinetics in overweight and obese people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes.
- Trial name
- NCT00476710
- Testing
- Colesevelam HCl
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- KineMed
Alzheimer's Disease, Dementia
Safety and Efficacy of High Dose, Rapid Titration Galantamine in Patients With Alzheimer's Disease
The purpose of this study was to determine the safety and effectiveness of a relatively high dose of galantamine, 32 mg /day in a three-times daily dosage, compared with placebo in treating patients with Alzheimer's disease.
- Trial name
- NCT00338117
- Testing
- Galantamine hydrobromide
- Volunteers
- 554 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Type 2 Diabetes Mellitus, Liver Dysfunction
Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)
This clinical trial is designed to assess the effect of hepatic impairment on the pharmacokinetic and pharmacodynamic of glufast tablets 10 mg.
- Trial name
- NCT04349696
- Testing
- Mitiglinide
- Where
- 2 sites in Taiwan
- Volunteers
- 16 people
- Sponsor
- Orient Europharma Co., Ltd.
Age-associated Memory Impairment
Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline.
- Trial name
- PHAEO-FOUR (NCT05759910)
- Testing
- Brainphyt high dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Microphyt
Bladder Transitional Cell Carcinoma Stage IV
JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin
This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or…
- Trial name
- JASINT1 (NCT01599013)
- Testing
- Vinflunine, Gemcitabine, Vinflunine, Carboplatin
- Where
- France
- Volunteers
- 69 people
- Sponsor
- Pierre Fabre Medicament
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine…
- Trial name
- NCT07764679
- Testing
- [18F]Fluorbetazine injection
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HTA Co., Ltd.
Hepatic Impairment
Study of Single-dose DS-3201b in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.
- Trial name
- NCT04276662
- Testing
- DS-3201b
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Insufficiency
Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.
- Trial name
- NCT01019070
- Testing
- BMS-650032
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS)
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients.
- Conditions
- Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- Trial name
- NCT05534620
- Testing
- Treosulfan, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- medac GmbH
Hepatic Impairment
A Single and Repeat Dose Trial in Participants With Hepatic Impairment
This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh…
- Trial name
- NCT05009680
- Testing
- GB1211
- Where
- 4 sites in Bulgaria
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Galecto Biotech AB
PK Properties Of Gabapentin In Subjects With Impaired Renal Function
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package…
- Trial name
- NCT00584779
- Testing
- Gabapentin
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Mild Cognitive Impairment, Normal Aging
An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with…
- Trial name
- Intuition (NCT05058950)
- Where
- United States
- Volunteers
- 22,720 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Participants
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100
- Trial name
- NCT05537142
- Testing
- BV100
- Where
- Hungary
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- BioVersys AG
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