- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01288898
Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941
February 1, 2011 updated by: Astellas Pharma Inc
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Groningen, Netherlands, 9470 AE
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
Time Frame: 31 days
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31 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics assessed by the ASP1941 plasma concentration change
Time Frame: up to 96 hours after last dose
|
up to 96 hours after last dose
|
Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine
Time Frame: up to 96 hours after last dose
|
up to 96 hours after last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
February 1, 2011
First Submitted That Met QC Criteria
February 1, 2011
First Posted (Estimate)
February 3, 2011
Study Record Updates
Last Update Posted (Estimate)
February 3, 2011
Last Update Submitted That Met QC Criteria
February 1, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1941-CL-0002
- 2006-006525-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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