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

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ClinicalTrials.gov Identifier: NCT00965978
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : October 5, 2009
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by:
Astellas Pharma Inc

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pharmacokinetic parameter of ONO-5920/YM529 [ Time Frame: For 48 hours ]


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Ages Eligible for Study:   45 Years to 81 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965978


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00965978     History of Changes
Other Study ID Numbers: 529-CL-027
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: October 5, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs