A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-

This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Pharmacokinetics of ASP1941
• Intervention / Treatment: Drug: ASP1941; Drug: placebo

Detailed Description

This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kantou, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight: 50.0 kg ≤ weight < 85.0 kg
• Body mass index:17.6 ≤ BMI < 26.4
• Those who provided written informed consent themselves

Exclusion Criteria:

• Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
• Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
• Those whose lab-test results are in the abnormal range
• Those who received medical treatment within 14 days prior to the study
• Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
• Those who have received ASP1941 before
• Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
• Those within a fasting plasma glucose level of < 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP1941 single arm	Drug: ASP1941; oral
Experimental: ASP1941 repeated arm	Drug: ASP1941; oral
Placebo Comparator: placebo single arm	Drug: placebo; oral
Placebo Comparator: placebo repeated arm	Drug: placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests	72 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of unchanged drug measured by blood sample	72 hours after drug administration
Blood glucose level measured by blood sample	72 hours after drug administration
Urinary glucose excretion level	72 hours after drug administration

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): May 12, 2010
• Last Update Submitted That Met QC Criteria: May 10, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Food effect
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Ipragliflozin
• Other Study ID Numbers: 1941-CL-0101