A Study to Compare the Pharmacokinetics of YM150 Formulat... | NCT01125657

Studies
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B

NCT01125657

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

May 25, 2010Estimated

Enrollment

44Actual

Phase

Phase 1

Conditions

Healthy Volunteer
Pharmacokinetics of YM150

Interventions

YM150

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

Feb 2010

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 17, 2010

First Submission Date that Met QC Criteria

May 17, 2010

First Posted Date

May 18, 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 24, 2010

Last Update Posted Date

May 25, 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

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

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
formualation-A to -B sequence group	Experimental		Drug: YM150
formulation-B to -A sequence group	Experimental		Drug: YM150

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM150	Drug	oral	formualation-A to -B sequence group formulation-B to -A sequence group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of YM150 and its metabolites measured by blood sample		for 3 days after drug administration

Secondary Outcomes

Measure	Description	Time Frame
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests		or 3 days after drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body weight: ≥50.0 kg, <80.0 kg
BMI: ≥17.6, <26.4
Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria:

Received any investigational drugs within 120 days before the study
Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
Received medication within 7 days before the study
A deviation from the assessment criteria of physical examinations or laboratory tests
A deviation from the normal reference range of coagulation test [PT (INR) or aPTT]
History of drug allergies
Upper gastrointestinal disease within 7 days before the study
Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
Concurrent or previous malignant tumor
Previous treatment with YM150

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