A Study to Evaluate Food Effect on ONO-5920/YM529 Intermi... | NCT00965978

Studies
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation

NCT00965978

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 5, 2009Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases

Interventions

ONO-5920 / YM529

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

Oct 2009

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

Jul 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 25, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 26, 2009Estimated

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 1, 2009

Last Update Posted Date

Oct 5, 2009Estimated

Name	Class
Ono Pharma USA 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

The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.

Detailed Description

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose group	Experimental	Receives low dose of ONO-5920/YM529 with and without food	Drug: ONO-5920 / YM529
High dose group	Experimental	Receives high dose of ONO-5920/YM529 with and without food	Drug: ONO-5920 / YM529

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-5920 / YM529	Drug	oral	High dose group Low dose group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameter of ONO-5920/YM529		For 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post menopausal women (at least 2 years after menopause)
Body weight: more than 40.0 Kg and less than 70.0 Kg
BMI: more than 17.6 and less than 30.0

Exclusion Criteria:

Receives investigational drug within 120 day before the study
Blood donation before the study
With abnormal laboratory values

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

81 Years

Standard Ages

AdultOlder 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
D010024	Osteoporosis
D015663	Osteoporosis, Postmenopausal
D001847	Bone Diseases

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C087958	YM 529

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided