Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults

Inclusion criteria

• Male or female, healthy non-elderly (age 18-45 years, inclusive) or healthy elderly (age 65 or over)
• If female, subject is not pregnant or nursing, and uses medically acceptable contraceptive method to prevent pregnancy from screening until study discharge
• Body weigh between 60 and 100kg and body Mass Index between 20 and 30kg/m2, inclusive
• Negative urine screen for drugs of abuse, including alcohol and cotinine

Exclusion criteria

• History of type 1 or type 2 diabetes
• Fasting plasma glucose level higher than 6.4mmol/L or hemoglobin A1c level higher than 6.2%
• Presence of renal glucosuria and/or proteinuria
• Clinically significant history of asthma, eczema, and or any other allergic condition.
• Clinically significant history of upper gastrointestinal symptoms within the 4 weeks prior to admission to the clinical unit.
• History of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that would preclude participation in the study.
• History of multiple drug allergies or a known allergy or suspected hypersensitivity to the study drug or any chemically related derivatives of the study drug or any components of the formulation
• Has hepatitis or a positive result to serology test for hepatitis A antibody Immunoglobulin M, hepatitis B surface antigen or hepatitis C virus at screening
• Known to be positive for human immunodeficiency virus antibodies.
• Donated one unit (450 mL) or more of blood or plasma within 60 days prior to the first dose of study medication.
• Has a history of consuming more than an average of 2 ounces of alcohol-containing products per day or a history of alcoholism or drug/chemical abuse within the last 3 years.
• Use of any tobacco or nicotine-containing products within 120 days prior to the first dose of study medication.
• Taken any prescribed systemic or topical medication within 21 days prior to the first dose of study medication with the exception of contraceptives to prevent pregnancy.
• Taken any systemic or topical over-the counter medication, complementary or alternative medications, e.g., vitamins, herbal, or nutritional supplements, with the exception of acetaminophen, within 10 days prior to the first dose of study medication.
• Taken an investigational drug within 30 days of the first dose of study medication