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

October 10, 2011 updated by: Astellas Pharma Inc

A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Drug: Placebo
oral
Experimental: ASP1941 group
Drug: ASP1941
oral
Other Names:
  • ipragliflozin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax of ASP1941 plasma concentration
Time Frame: up to 72 hours
up to 72 hours
AUC (Area under the curve) of ASP1941 plasma concentration
Time Frame: up to 72 hours
up to 72 hours
Changes in plasma glucose
Time Frame: baseline and up to 72 hours
baseline and up to 72 hours
Changes in urine glucose
Time Frame: baseline and up to 72 hours
baseline and up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Taiwan, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 10, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1941-CL-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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