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

This study has been completed.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00965978
First received: August 25, 2009
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
 Drug: ONO-5920 / YM529
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic parameter of ONO-5920/YM529 [ Time Frame: For 48 hours ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose group
Receives low dose of ONO-5920/YM529 with and without food
 Drug: ONO-5920 / YM529
oral
Other Name: Minodronic Acid
Experimental: High dose group
Receives high dose of ONO-5920/YM529 with and without food
 Drug: ONO-5920 / YM529
oral
Other Name: Minodronic Acid

  Eligibility

Ages Eligible for Study:   45 Years to 81 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965978

Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Ono Pharma USA Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00965978     History of Changes
Other Study ID Numbers: 529-CL-027
Study First Received: August 25, 2009
Last Updated: October 1, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ONO-5920
YM529
Minodronic Acid
Food Effect

Additional relevant MeSH terms:
Bone Diseases
Osteoporosis
Osteoporosis, Postmenopausal
Musculoskeletal Diseases
Bone Diseases, Metabolic

ClinicalTrials.gov processed this record on May 22, 2013