Abstract

This open-label multiple dose non-randomized study is undertaken to determine steady state pharmacokinetic (PK) and pharmacodynamic (PD) profiles of donepezil hydrochloride (Aricept) in patients with impaired renal function and in healthy subjects. Subjects with renal impairment will be age, gender, and weight matched with healthy subjects. A total of 16 patients with renal impairment and 16 subjects with normal renal function from two sites will be enrolled, with each site completing 8 subjects in each group. Subjects will be involved in the study for 7 weeks. Procedures will be done outpatient and inpatient and include:1) screening and safety lab evaluations, 2) screening and safety physical exams, 3) two (2) day General Clinical Research Center (GCRC) hospitalizations, and 4)PK and PD blood samples collected throughout the study period. The study aims to demonstrate safety and tolerance of the drug (Aricept) in renal impaired patients.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000847-27
Application #
6412530
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1985-12-01
Project End
2001-02-28
Budget Start
Budget End
Support Year
27
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
University of Virginia
Department
Type
DUNS #
001910777
City
Charlottesville
State
VA
Country
United States
Zip Code
22904

  Publications

Campbell, Garland A; Patrie, James T; Gaylinn, Bruce D et al. (2018) Oral ghrelin receptor agonist MK-0677 increases serum insulin-like growth factor 1 in hemodialysis patients: a randomized blinded study. Nephrol Dial Transplant 33:523-530
Malin, Steven K; Rynders, Corey A; Weltman, Judy Y et al. (2016) Endothelial function following glucose ingestion in adults with prediabetes: Role of exercise intensity. Obesity (Silver Spring) 24:1515-21
Rynders, Corey A; Weltman, Judy Y; Malin, Steven K et al. (2016) Comparing Simple Insulin Sensitivity Indices to the Oral Minimal Model Postexercise. Med Sci Sports Exerc 48:66-72
Hu, Yinin; Kim, Helen; Blackwell, Christopher M et al. (2015) Long-term outcomes of helper peptide vaccination for metastatic melanoma. Ann Surg 262:456-64; discussion 462-4
Marozkina, Nadzeya V; Wang, Xin-Qun; Stsiapura, Vitali et al. (2015) Phenotype of asthmatics with increased airway S-nitrosoglutathione reductase activity. Eur Respir J 45:87-97
Nass, Ralf; Nikolayev, Alexander; Liu, Jianhua et al. (2015) The level of circulating octanoate does not predict ghrelin O-acyl transferase (GOAT)-mediated acylation of ghrelin during fasting. J Clin Endocrinol Metab 100:E110-3
Argo, Curtis K; Patrie, James T; Lackner, Carolin et al. (2015) Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol 62:190-7
Chyun, Deborah A; Wackers, Frans J Th; Inzucchi, Silvio E et al. (2015) Autonomic dysfunction independently predicts poor cardiovascular outcomes in asymptomatic individuals with type 2 diabetes in the DIAD study. SAGE Open Med 3:2050312114568476
Hu, Yinin; Petroni, Gina R; Olson, Walter C et al. (2014) Immunologic hierarchy, class II MHC promiscuity, and epitope spreading of a melanoma helper peptide vaccine. Cancer Immunol Immunother 63:779-86
Paige, Mikell; Wang, Kan; Burdick, Marie et al. (2014) Role of leukotriene A4 hydrolase aminopeptidase in the pathogenesis of emphysema. J Immunol 192:5059-68

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