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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01373060
First received: May 31, 2011
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
Pharmacokinetics of ASP1941
 Drug: ASP1941
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of ASP1941 plasma concentration [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • AUC (Area under the curve) of ASP1941 plasma concentration [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • Changes in plasma glucose [ Time Frame: baseline and up to 72 hours ] [ Designated as safety issue: No ]
  • Changes in urine glucose [ Time Frame: baseline and up to 72 hours ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 group Drug: ASP1941
oral
Other Name: ipragliflozin
Placebo Comparator: placebo group Drug: Placebo
oral

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373060

Locations
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01373060     History of Changes
Other Study ID Numbers: 1941-CL-2001
Study First Received: May 31, 2011
Last Updated: October 10, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
ASP1941
ipragliflozin
plasma glucose
urine glucose

ClinicalTrials.gov processed this record on May 21, 2013