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

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of ASP1941
• Interventions: Drug: Placebo; Drug: ASP1941

• Registration Number: NCT01373060
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	-
ASP1941 group	ASP1941	-

Primary Outcome Measures

Name	Time	Method
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG	up to 72 hours

Secondary Outcome Measures

Name	Time	Method
Cmax of ASP1941 plasma concentration	up to 72 hours
AUC (Area under the curve) of ASP1941 plasma concentration	up to 72 hours
Changes in plasma glucose	baseline and up to 72 hours
Changes in urine glucose	baseline and up to 72 hours