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

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of ASP1941; Healthy Volunteers

Treatments: Drug: ASP1941; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01678287

1941-CL-0052

Details and patient eligibility

About

This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy adult male and female subjects.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

65 participants in 4 patient groups

Arm 1 Non elderly receiving ASP1941

Experimental group

Description:

healthy subjects age 18 to 45 years receiving ASP1941

Treatment:

Drug: ASP1941

Arm 2 Non elderly receiving placebo

Experimental group

Description:

healthy subjects age 18 to 45 years receiving placebo

Treatment:

Drug: Placebo

Arm 3 Elderly receiving ASP1941

Experimental group

Description:

healthy subjects age ≥ 65 years receiving ASP1941

Treatment:

Drug: ASP1941

Arm 4 Elderly receiving placebo

Experimental group

Description:

healthy subjects age ≥ 65 years receiving placebo

Treatment:

Drug: Placebo