A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of ASP1941

Healthy

Treatments

Drug: Placebo

Drug: ASP1941

Study type

Interventional

Funder types

Industry

Identifiers

NCT01373060

1941-CL-2001

Details and patient eligibility

About

This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.

Full description

The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.

Enrollment

56 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

Exclusion criteria

Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
Labo test results deviate from preset normal range
Receiving treatment, including medication, within 14 days before the study
Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study
Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day
Employed by the sponsor, delegated CRO or the study site
Fasting plasma glucose level of < 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%
Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2