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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121198
• Other study ID #: 1941-CL-0101
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2010
• Last updated: May 10, 2010
• Start date: December 2006
• Est. completion date: July 2007

Study information

• Verified date: May 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics of ASP1941

Intervention

Drug:
• ASP1941
oral
• placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests		72 hours after drug administration	No
Secondary	Plasma concentration of unchanged drug measured by blood sample		72 hours after drug administration	No
Secondary	Blood glucose level measured by blood sample		72 hours after drug administration	No
Secondary	Urinary glucose excretion level		72 hours after drug administration	No