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

NCT ID: NCT01678287

Last Updated: 2012-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-01-31

Brief Summary

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.

Conditions

Healthy Volunteers; Pharmacokinetics of ASP1941

Keywords

ASP1941

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1 Non elderly receiving ASP1941

healthy subjects age 18 to 45 years receiving ASP1941

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral

Arm 2 Non elderly receiving placebo

healthy subjects age 18 to 45 years receiving placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

oral

Arm 3 Elderly receiving ASP1941

healthy subjects age ≥ 65 years receiving ASP1941

Group Type: EXPERIMENTAL

ASP1941

Intervention Type: DRUG

oral

Arm 4 Elderly receiving placebo

healthy subjects age ≥ 65 years receiving placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

oral

Interventions

ASP1941

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Comprehensive Phase One

Miramar, Florida, United States

Countries

United States

Other Identifiers

1941-CL-0052

Identifier Type: -

Identifier Source: org_study_id