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

May 31, 2011
October 10, 2011
February 2011
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01373060 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Healthy
  • Pharmacokinetics of ASP1941
  • Drug: ASP1941
    oral
    Other Name: ipragliflozin
  • Drug: Placebo
    oral
  • Experimental: ASP1941 group
    Intervention: Drug: ASP1941
  • Placebo Comparator: placebo group
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01373060
1941-CL-2001
No
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP