Kantou, Japan
NCT Number: NCT01121198
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects
This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.
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Notify MeKey information
Conditions
Age range
20 year–44 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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%
Treatment and study plan
ASP1941
Drugoral
Placebo
Drugoral
Primary outcomes
-
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
Time frame: 72 hours after drug administration
Secondary outcomes
-
Plasma concentration of unchanged drug measured by blood sample
Time frame: 72 hours after drug administration
-
Blood glucose level measured by blood sample
Time frame: 72 hours after drug administration
-
Urinary glucose excretion level
Time frame: 72 hours after drug administration
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study title
ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- May 12, 2010
- Registry last updated
- May 12, 2010
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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