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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteer Pharmacokinetics of ASP1941

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo repeated arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

ASP1941 single arm

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

ASP1941 repeated arm

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

placebo single arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

Interventions

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ASP1941

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes