A Study to Assess Safety and Tolerability of ASP1941 Afte... | NCT01121198

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

NCT01121198

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

May 12, 2010Estimated

Enrollment

84Actual

Phase

Phase 1

Conditions

Healthy Volunteer
Pharmacokinetics of ASP1941

Interventions

ASP1941
placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

May 10, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2010

Last Update Posted Date

May 12, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ASP1941 single arm	Experimental	Drug: ASP1941
ASP1941 repeated arm	Experimental	Drug: ASP1941
placebo single arm	Placebo Comparator	Drug: placebo
placebo repeated arm	Placebo Comparator	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral	ASP1941 repeated arm ASP1941 single arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided