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

Phase 1

Completed

• Conditions: Pharmacokinetics of ASP1941; Healthy Volunteer
• Interventions: Drug: ASP1941; Drug: placebo

• Registration Number: NCT01121198
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Study First Posted: 2010-05-12
• Last Update Posted: 2010-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP1941 single arm	ASP1941	-
ASP1941 repeated arm	ASP1941	-
placebo single arm	placebo	-
placebo repeated arm	placebo	-

Primary Outcome Measures

Name	Time	Method
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests	72 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Urinary glucose excretion level	72 hours after drug administration
Blood glucose level measured by blood sample	72 hours after drug administration
Plasma concentration of unchanged drug measured by blood sample	72 hours after drug administration