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Early Phase Metabolic Research with Reference to Special Populations

  • Linda A. MorrowEmail author
  • Andrew J. Krentz
Chapter

Abstract

Well-designed and expertly executed early phase clinical trials can provide valuable information that may accelerate ‘go, no go’ decisions, potentially shortening the time of access to new, more efficacious treatments. While first-in-human studies had conventionally been performed in healthy volunteers, more recently there has been acceptance of the use of patients with the disease of interest. In the context of developing new drugs for the treatment of diabetes, obesity, and nonalcoholic steatohepatitis (NASH), this paradigm shift requires consideration of the risks, benefits, and practical challenges of studying patients with obesity, nonalcoholic fatty liver disease (NAFLD), glucose intolerance, type 1 diabetes, and type 2 diabetes. Within these disorders, issues of renal impairment, impaired liver function tests, the metabolic syndrome, and cognitive impairment demand additional consideration. In addition, safe and ethical inclusion of patients with special characteristics, e.g. the pediatric and adolescent age groups, older subjects, and women of childbearing potential, in early phase studies mandates specific risk management strategies. Access to these patient populations and rapid identification of potential volunteers for trials remain critical factors for successful early drug development.

Keywords

Early phase clinical trials Obesity Cardiovascular disease Fatty liver disease Diabetic nephropathy Type 1 diabetes Type 2 diabetes Impaired glucose tolerance Older people Women of childbearing potential Diabetes in childhood 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.ProSciento, Inc.Chula VistaUSA

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