Healthy Post Menopausal WomenPhase 1/2NCT01384188
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 Phase 1/2 study testing ONO-5334 in people with Healthy Post Menopausal Women, run by Ono Pharmaceutical Co., Ltd. at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Post Menopausal Women
- What is being tested?
- ONO-5334
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guildford Clinical Site
Guildford, Surrey, GU2 7XP
London Clinical Site
London, SE1 1YR
About this study
Official title: 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
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.
Read the detailed description
This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.
- Conditions
- Healthy Post Menopausal Women
- Being tested
- ONO-5334
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5334Drug
150 mg for 5 days administered in the morning or in the evening
ONO-5334Drug
150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | ONO-5334 Receives: Drug: ONO-5334 |
| E2 | Experimental | ONO-5334 Receives: Drug: ONO-5334 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334
Measured: 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
Measured: end of day 1
Secondary outcomes (1)
Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women
Measured: up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Post Menopausal WomenStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma UK LTD, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384188
- Sponsor's protocol ID
- ONO-5334POE010
- Other IDs
- 2010-018282-36
- Status last verified
- Jul 2012
- First submitted
- 27 Jun 2011
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26446770
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01384188
- Acronym / sponsor ID
- ONO-5334POE010
- Conditions
- Healthy Post Menopausal Women
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Drug: ONO-5334ONO-5334 |
| E2 | Experimental | Drug: ONO-5334ONO-5334 |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-5334150 mg for 5 days administered in the morning or in the evening | Drug | E1 |
| ONO-5334150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal. | Drug | E2 |
Primary outcome
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334
Time frame: 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
Time frame: end of day 1
1 secondary outcome
Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women
Time frame: up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Derived from this study: PubMed 26446770Eastell 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.
Related trials for Healthy Post Menopausal Women
Not yet recruiting
Women's Healthy Aging and Menopause; (WHAM)
Meditation, Health Education
Recruiting
Nitrate, Exercise and Vascular Function in Midlife Women
Healthy, Menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ono Pharma UK LTD study director
Ono Pharmaceutical Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ONO-5334 in people with Healthy Post Menopausal Women, run by Ono Pharmaceutical Co., Ltd. at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334 (time frame: end of treatment (5 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.