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

NCT01373060 | Completed Phase 1

• 1 other identifier: 1941-CL-2001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Pharmacokinetics of ASP1941

Keywords

ASP1941; ipragliflozin; plasma glucose; urine glucose

Outcome Measures

Primary Outcomes (1)

• Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG

  up to 72 hours

Secondary Outcomes (4)

• Cmax of ASP1941 plasma concentration

  up to 72 hours

• AUC (Area under the curve) of ASP1941 plasma concentration

  up to 72 hours

• Changes in plasma glucose

  baseline and up to 72 hours

• Changes in urine glucose

  baseline and up to 72 hours

Study Arms (2)

ASP1941 group

EXPERIMENTAL

Drug: ASP1941

placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP1941 DRUG

oral

Also known as: ipragliflozin

ASP1941 group

Placebo DRUG

oral

placebo group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Taiwan, Inc.: collaborator

Study Sites (1)

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Glycosuria

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 14, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

TW (1)