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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01373060
Collaborator
Astellas Pharma Taiwan, Inc. (Industry)
56
Enrollment
1
Location
2
Arms
28
Duration (Days)
60.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
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
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASP1941 group

Drug: ASP1941
oral
Other Names:
  • ipragliflozin

    		•
    Placebo Comparator: placebo group

    Drug: Placebo
    oral

    Outcome Measures

    Primary Outcome Measures

    1. Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG [up to 72 hours]

    Secondary Outcome Measures

    1. Cmax of ASP1941 plasma concentration [up to 72 hours]

    2. AUC (Area under the curve) of ASP1941 plasma concentration [up to 72 hours]

    3. Changes in plasma glucose [baseline and up to 72 hours]

    4. Changes in urine glucose [baseline and up to 72 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Taiwan

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Astellas Pharma Taiwan, Inc.

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01373060
    Other Study ID Numbers:
    • 1941-CL-2001
    First Posted:
    Jun 14, 2011
    Last Update Posted:
    Oct 12, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Astellas Pharma Inc
    ASP1941
    ipragliflozin
    plasma glucose
    urine glucose
    Additional relevant MeSH terms:
    Ipragliflozin

    Study Results

    No Results Posted as of Oct 12, 2011