A Study to Investigate the Effects of Food and Morning Versus Evening on Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women
A Two-part, Crossover Study to Investigate the Effects of Morning Versus Evening Dosing and Food Interaction on the Pharmacodynamics and Pharmacokinetics of Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women
2 other identifiers
interventional
25
1 country
2
Brief Summary
The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 18, 2013
July 1, 2012
6 months
June 27, 2011
January 17, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334
end of treatment (5 days)
Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334
end of day 1
Secondary Outcomes (1)
Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women
up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose)
Study Arms (2)
E1
EXPERIMENTALONO-5334
E2
EXPERIMENTALONO-5334
Interventions
Eligibility Criteria
You may qualify if:
- Healthy caucasian women aged between 55 to 75 years inclusive
- Subjects weighing at least 50 kg with mass index between 19 to 30 kg/m2 inclusive
- Subjects who have been amenorrhoeic for at least 5 years.
- Subjects who are confirmed at Screening Visit to have oestradiol and follicle stimulating hormone (FSH) levels consistent with menopause
You may not qualify if:
- Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
- Subjects who have a clinically relevant history of insomnia or sleep disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Guildford Clinical Site
Guildford, Surrey, GU2 7XP, United Kingdom
London Clinical Site
London, SE1 1YR, United Kingdom
Related Publications (1)
Eastell R, Dijk DJ, Small M, Greenwood A, Sharpe J, Yamada H, Yuba M, Tanimoto M, Deacon S. Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial. Osteoporos Int. 2016 Jan;27(1):309-18. doi: 10.1007/s00198-015-3342-4. Epub 2015 Oct 7.
PMID: 26446770DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Ono Pharma UK LTD
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2011
First Posted
June 28, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
January 18, 2013
Record last verified: 2012-07