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

NCT ID: NCT01373060

Last Updated: 2011-10-12

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Pharmacokinetics of ASP1941

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASP1941 group

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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ASP1941

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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ipragliflozin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Taiwan, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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1941-CL-2001

Identifier Type: -

Identifier Source: org_study_id