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NCT Number: NCT01373060

A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics 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.

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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Glycosuria Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pharmacokinetics of ASP1941 Urination Disorders Urogenital Diseases Urologic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP1941

Drug

oral

Other names: ipragliflozin

Placebo

Drug

oral

Primary outcomes

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

    Time frame: up to 72 hours

Secondary outcomes

  1. Cmax of ASP1941 plasma concentration

    Time frame: up to 72 hours

  2. AUC (Area under the curve) of ASP1941 plasma concentration

    Time frame: up to 72 hours

  3. Changes in plasma glucose

    Time frame: baseline and up to 72 hours

  4. Changes in urine glucose

    Time frame: baseline and up to 72 hours

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Taiwan, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2011
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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