OsteoporosisPhase 1NCT02295436
Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics
A Phase 1 study testing minodronic acid in people with Osteoporosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
The primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- minodronic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 2014
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects were included based on the following criteria:
- males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects
- body mass index between 19 and 24 kg/m2
- thorax radiography and ECG with no abnormalities
- normal blood pressure values
- heart rate
- laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis)
- negative test results for HIV and hepatitis B.
Who cannot join
- Subjects were excluded if they had a heart disease or disorder
- A hepatic, renal, respiratory, immune system, or nervous system disorder
- Any of the following conditions:
- pregnancy
- breast-feeding
- hypocalcemia
Show all 13Show fewer
- prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study
- blood donation or participation in other clinical trials within 3 months before enrollment in the study
- alcohol or drug abuse
- smoking more than 10 a day
- clinically significant allergies to drugs or foods
- sitting blood pressure <80/50 mm Hg or >140/100 mm Hg
- A ventricular rate <60 beats/min or >100 beats/min at rest.
About this study
Official title: Pharmacokinetics and Tolerability of Minodronic Acid Tablets in Healthy Chinese Subjects and Food and Age Effects on the Pharmacokinetics
The primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.
Read the detailed description
This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects.
- Conditions
- Osteoporosis
- Being tested
- minodronic acid
- Keywords
- minodronic acid, pharmacokinetics, tolerability, food, age, Chinese subjects
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minodronic acidDrug
Also called YM529/ONO-5920
comparison of different doses, ages and medication conditions
| Study group | Role | What they receive |
|---|---|---|
| 1-mg group | Experimental | Twelve healthy young subjects were administered a single oral dose of 1 mg minodronic acid tablets at day 1 and then received repeated oral doses of minodronic acid (1 mg) once daily for 7 days (day 3 to day 9). Receives: Drug: minodronic acid |
| 2-mg group | Experimental | Twelve healthy young subjects were administered a single oral dose of 2 mg minodronic acid tablets. Receives: Drug: minodronic acid |
| 4-mg group | Experimental | Twelve healthy young subjects were administered a single oral dose of 4 mg minodronic acid tablets under fasting state at period 1.After a washout period of 8 days, they received the same dosage under fed conditions (administrated 30 minutes before high-fat breakfast). Receives: Drug: minodronic acid |
| 1-mg elderly group | Experimental | Twelve healthy elderly subjects were administered a single oral dose of 1 mg minodronic acid tablets. Receives: Drug: minodronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
the maximum observed plasma concentration and
Measured: two months
AUC
the area under the concentration-time curve
Measured: two months
Secondary outcomes (1)
adverse events
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
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 OsteoporosisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyong Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Weiyong Li, PhD, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295436
- Sponsor's protocol ID
- WHXH-MINO
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhou Y, He X, Li H, Ni Y, Xu M, Sattar H, Chen H, Li W. Pharmacokinetics and tolerability of minodronic acid tablets in healthy Chinese subjects and food and age effects on the pharmacokinetics. Clin Ther. 2015 Apr 1;37(4):869-76. doi: 10.1016/j.clinthera.2015.01.015. Epub 2015 Mar 5.
PubMed 25748293
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Tolerability of Minodronic Acid Tablets in Healthy Chinese Subjects and Food and Age Effects on the Pharmacokinetics
- ClinicalTrials.gov ID
- NCT02295436
- Acronym / sponsor ID
- WHXH-MINO
- Conditions
- Osteoporosis
- Keywords
- minodronic acid, pharmacokinetics, tolerability, food, age, Chinese subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 2014 (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 primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.
Detailed description
This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1-mg group | Experimental | Drug: minodronic acidTwelve healthy young subjects were administered a single oral dose of 1 mg minodronic acid tablets at day 1 and then received repeated oral doses of minodronic acid (1 mg) once daily for 7 days (day 3 to day 9). |
| 2-mg group | Experimental | Drug: minodronic acidTwelve healthy young subjects were administered a single oral dose of 2 mg minodronic acid tablets. |
| 4-mg group | Experimental | Drug: minodronic acidTwelve healthy young subjects were administered a single oral dose of 4 mg minodronic acid tablets under fasting state at period 1.After a washout period of 8 days, they received the same dosage under fed conditions (administrated 30 minutes before high-fat breakfast). |
| 1-mg elderly group | Experimental | Drug: minodronic acidTwelve healthy elderly subjects were administered a single oral dose of 1 mg minodronic acid tablets. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects were included based on the following criteria:
Key exclusion criteria (13 listed)
- Subjects were excluded if they had a heart disease or disorder
- A hepatic, renal, respiratory, immune system, or nervous system disorder
- Any of the following conditions:
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 |
|---|---|---|
| minodronic acidAlso: YM529/ONO-5920comparison of different doses, ages and medication conditions | Drug | 1-mg elderly group, 1-mg group, 2-mg group, 4-mg group |
Primary outcome
Cmax
Time frame: two months
the maximum observed plasma concentration and
AUC
Time frame: two months
the area under the concentration-time curve
1 secondary outcome
adverse events
Time frame: two months
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 20 Nov 2014.
- Derived from this study: PubMed 25748293Zhou Y, He X, Li H, Ni Y, Xu M, Sattar H, Chen H, Li W. Pharmacokinetics and tolerability of minodronic acid tablets in healthy Chinese subjects and food and age effects on the pharmacokinetics. Clin Ther. 2015 Apr 1;37(4):869-76. doi: 10.1016/j.clinthera.2015.01.015. Epub 2015 Mar 5.
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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.
Weiyong Li, PhD principal investigator
Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing minodronic acid in people with Osteoporosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 8 inclusion and 13 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax (time frame: two months). 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 NCT02295436, 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 20 Nov 2014.