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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:
ClinicalTrials.gov Identifier:
NCT01373060
First Posted: June 14, 2011
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
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

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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01373060     History of Changes
Other Study ID Numbers: 1941-CL-2001
First Submitted: May 31, 2011
First Posted: June 14, 2011
Last Update Posted: October 12, 2011
Last Verified: October 2011

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