Back to resultsA Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
Primary Purpose
Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ONO-5920 / YM529
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring ONO-5920, YM529, Minodronic Acid, Food Effect
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose group
High dose group
Arm Description
Receives low dose of ONO-5920/YM529 with and without food
Receives high dose of ONO-5920/YM529 with and without food
Outcomes
Primary Outcome Measures
Pharmacokinetic parameter of ONO-5920/YM529
Secondary Outcome Measures
Full Information
NCT ID
NCT00965978
First Posted
August 25, 2009
Last Updated
October 1, 2009
Sponsor
Astellas Pharma Inc
Collaborators
Ono Pharma USA Inc
1. Study Identification
Unique Protocol Identification Number
NCT00965978
Brief Title
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
Official Title
A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Ono Pharma USA Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases
Keywords
ONO-5920, YM529, Minodronic Acid, Food Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
Receives low dose of ONO-5920/YM529 with and without food
Arm Title
High dose group
Arm Type
Experimental
Arm Description
Receives high dose of ONO-5920/YM529 with and without food
Intervention Type
Drug
Intervention Name(s)
ONO-5920 / YM529
Other Intervention Name(s)
Minodronic Acid
Intervention Description
oral
Primary Outcome Measure Information:
Title
Pharmacokinetic parameter of ONO-5920/YM529
Time Frame
For 48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Kantou
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
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