A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of ASP1941

Healthy Volunteer

Treatments

Drug: placebo

Drug: ASP1941

Study type

Interventional

Funder types

Industry

Identifiers

NCT01121198

1941-CL-0101

Details and patient eligibility

About

This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Full description

This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.

Enrollment

84 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body weight: 50.0 kg ≤ weight < 85.0 kg
Body mass index:17.6 ≤ BMI < 26.4
Those who provided written informed consent themselves

Exclusion criteria

Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
Those whose lab-test results are in the abnormal range
Those who received medical treatment within 14 days prior to the study
Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
Those who have received ASP1941 before
Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
Those within a fasting plasma glucose level of < 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%