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NCT01288898 Clinical Trial

Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941

Healthy Clinical Trial

Official title:
A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of ASP1941 and to Explore the Effect of ASP1941 on Urine and Blood Glucose Levels in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01288898
Other study ID # 1941-CL-0002
Secondary ID 2006-006525-11
Status Completed
Phase Phase 1
First received February 1, 2011
Last updated February 1, 2011
Start date May 2007
Est. completion date March 2008

Study information
Verified date February 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive

Exclusion Criteria:

- Fasting Plasma Glucose (FPG) > 6.4 mmol/l

- HbA1c > 6.2%

- Abnormal pulse of blood pressure at screening, as judged by the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests 31 days No
Secondary Pharmacokinetics assessed by the ASP1941 plasma concentration change up to 96 hours after last dose No
Secondary Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine up to 96 hours after last dose No
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