A Study to Assess the Safety, Pharmacokinetics and Pharma... | NCT01373060

Studies
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects

NCT01373060

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 12, 2011Estimated

Enrollment

56Actual

Phase

Phase 1

Conditions

Healthy
Pharmacokinetics of ASP1941

Interventions

ASP1941
Placebo

Countries

Taiwan

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

Oct 2011

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

Feb 2011

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 31, 2011

First Submission Date that Met QC Criteria

Jun 13, 2011

First Posted Date

Jun 14, 2011Estimated

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

Oct 10, 2011

Last Update Posted Date

Oct 12, 2011Estimated

Name	Class
Astellas Pharma Taiwan, Inc.	INDUSTRY

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 assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.

Detailed Description

The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.

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

56Actual

Label	Type	Description	Intervention Names
ASP1941 group	Experimental		Drug: ASP1941
placebo group	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral	ASP1941 group	ipragliflozin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG		up to 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Cmax of ASP1941 plasma concentration		up to 72 hours
AUC (Area under the curve) of ASP1941 plasma concentration		up to 72 hours
Changes in plasma glucose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

Exclusion Criteria:

Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
Labo test results deviate from preset normal range
Receiving treatment, including medication, within 14 days before the study
Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study
Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day
Employed by the sponsor, delegated CRO or the study site
Fasting plasma glucose level of < 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%
Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D006029	Glycosuria

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided