OsteoporosisPhase 1NCT00965978
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
A Phase 1 study testing ONO-5920 / YM529 in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Astellas Pharma Inc at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 81 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases
- What is being tested?
- ONO-5920 / YM529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2009to Sep 2009
- Phase
- Phase 1
- 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 45 to 81 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Receives investigational drug within 120 day before the study
- Blood donation before the study
- With abnormal laboratory values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation
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.
- Conditions
- Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases
- Being tested
- ONO-5920 / YM529
- Keywords
- ONO-5920, YM529, Minodronic Acid, Food Effect
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5920 / YM529Drug
Also called Minodronic Acid
oral
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | Receives low dose of ONO-5920/YM529 with and without food Receives: Drug: ONO-5920 / YM529 |
| High dose group | Experimental | Receives high dose of ONO-5920/YM529 with and without food Receives: Drug: ONO-5920 / YM529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of ONO-5920/YM529
Measured: For 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965978
- Sponsor's protocol ID
- 529-CL-027
- Status last verified
- Oct 2009
- First submitted
- 25 Aug 2009
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation
- ClinicalTrials.gov ID
- NCT00965978
- Acronym / sponsor ID
- 529-CL-027
- Conditions
- Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases
- Keywords
- ONO-5920, YM529, Minodronic Acid, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Aug 2009 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: ONO-5920 / YM529Receives low dose of ONO-5920/YM529 with and without food |
| High dose group | Experimental | Drug: ONO-5920 / YM529Receives high dose of ONO-5920/YM529 with and without food |
Who may qualify
- Ages
- 45 to 81 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Receives investigational drug within 120 day before the study
- Blood donation before the study
- With abnormal laboratory values
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-5920 / YM529Also: Minodronic Acidoral | Drug | High dose group, Low dose group |
Primary outcome
Pharmacokinetic parameter of ONO-5920/YM529
Time frame: For 48 hours
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 5 Oct 2009.
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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.
Use Central Contact study chair
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-5920 / YM529 in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Astellas Pharma Inc at 1 site in Japan.
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 3 inclusion and 3 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 5 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 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.
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?
Pharmacokinetic parameter of ONO-5920/YM529 (time frame: For 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2009.