Healthy VolunteerPhase 1NCT01125657
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
A Phase 1 study testing YM150 in people with Healthy Volunteer and Pharmacokinetics of YM150, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Pharmacokinetics of YM150
- What is being tested?
- YM150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Mar 2010
- 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 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests
Who cannot join
- Received any investigational drugs within 120 days before the study
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
- Received medication within 7 days before the study
- A deviation from the assessment criteria of physical examinations or laboratory tests
- A deviation from the normal reference range of coagulation test [PT (INR) or aPTT]
- History of drug allergies
Show all 10Show fewer
- Upper gastrointestinal disease within 7 days before the study
- Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
- Concurrent or previous malignant tumor
- Previous treatment with YM150
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.
- Conditions
- Healthy Volunteer, Pharmacokinetics of YM150
- Being tested
- YM150
- Keywords
- YM150, bioequivalence study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| formualation-A to -B sequence group | Experimental | Not described Receives: Drug: YM150 |
| formulation-B to -A sequence group | Experimental | Not described Receives: Drug: YM150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of YM150 and its metabolites measured by blood sample
Measured: for 3 days after drug administration
Secondary outcomes (1)
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
Measured: or 3 days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125657
- Sponsor's protocol ID
- 150-CL-046
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -
- ClinicalTrials.gov ID
- NCT01125657
- Acronym / sponsor ID
- 150-CL-046
- Conditions
- Healthy Volunteer, Pharmacokinetics of YM150
- Keywords
- YM150, bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 May 2010 (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.
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| formualation-A to -B sequence group | Experimental | Drug: YM150 |
| formulation-B to -A sequence group | Experimental | Drug: YM150 |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests
Key exclusion criteria (10 listed)
- Received any investigational drugs within 120 days before the study
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
- Received medication within 7 days before the study
- A deviation from the assessment criteria of physical examinations or laboratory tests
- A deviation from the normal reference range of coagulation test [PT (INR) or aPTT]
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 |
|---|---|---|
| YM150oral | Drug | formualation-A to -B sequence group, formulation-B to -A sequence group |
Primary outcome
Plasma concentration of YM150 and its metabolites measured by blood sample
Time frame: for 3 days after drug administration
1 secondary outcome
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
Time frame: or 3 days after drug administration
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 25 May 2010.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 YM150 in people with Healthy Volunteer and Pharmacokinetics of YM150, 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 10 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 25 May 2010. 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?
Plasma concentration of YM150 and its metabolites measured by blood sample (time frame: for 3 days after drug administration). 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 25 May 2010.