A Pharmacokinetic Study to Investigate the Effect of Food... | NCT01118559

Studies
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150

NCT01118559

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

May 6, 2010Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy
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

Nov 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

May 5, 2010

First Submission Date that Met QC Criteria

May 5, 2010

First Posted Date

May 6, 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 5, 2010

Last Update Posted Date

May 6, 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 evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.

Detailed Description

To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fast-fed sequence group	Experimental	drug is administered in a fasted condition first, and fed-condition study follows	Drug: YM150
fed-fast sequence group	Experimental	drug is administered in a fed condition first, and fasted-condition study follows	Drug: YM150

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM150	Drug	oral	fast-fed sequence group fed-fast sequence group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests		for 3 days after drug administration
PT (prothrombin time)		for 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 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