HealthyPhase 1NCT01504984
Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
A Phase 1 study testing SYO-1126 and Glivec film coated tab 4T(400mg) in people with Healthy, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SYO-1126 and Glivec film coated tab 4T(400mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Apr 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20aged and 45aged in healthy males
- Over 55kg and BMI: 18.5~25 kg/m2
- Agreement with written informed consent
Who cannot join
- Subject with symptoms of acute disease at the time of screening
- Clinically significant cardiovascular system, pulmonary system, renal system, endocrine system, blood system, gastrointestinal system, nervous system, mental disease or malignant tumor
- Subject with known for gastrointestinal disease or surgical history which affect on absorption of drug
- An impossible one who participates in clinical trial by result of screening tests
- Inadequate result of laboratory test AST/ALT > 1.5 x UNL Total bilirubin > 1.5 X UNL
- Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
Show all 17Show fewer
- Subject with known for hypersensitivity reaction to imatinib analog
- Subject with known for history which drug abuse or show positive for it in screening tests
- Previously participate in other trial within 60 days
- Previously make whole blood donation within 60 days or component blood donation within 30 days
- Previously have blood transfusion within 30 days
- Not able to taking the institutional standard meal
- Subject who have had abnormal eating which affect on the ADME of drug
- Not able to taking the grapefruit-containing foods
- Taking ETC(ethical the counter)medicine including oriental medicine within 14 days or taking OTC(over the counter)medicine or vitamin preparations within 7 days
- Continued to be taking caffein(caffein>5cup/day), drinking (alcohol>30g/day) and severe heavy smoker(cigarette>1/2pack/day)
- An impossible one who participates in clinical trial by investigator's decision including for reason laboratory test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.
Read the detailed description
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
- Conditions
- Healthy
- Being tested
- SYO-1126, Glivec film coated tab 4T(400mg)
- Keywords
- Evaluation of the pharmacokinetics equivalence, Healthy volunteers, Single dose over the period I and II(crossover), Healthy male volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYO-1126Drug
Also called Imatinib 400mg
Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
Glivec film coated tab 4T(400mg)Drug
Also called Imatinib 100mg, Glivec film coated tab
Imatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover)
| Study group | Role | What they receive |
|---|---|---|
| SYO-1126 | Experimental | Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) Receives: Drug: SYO-1126 |
| Glivec film coated tab 4T(400mg) | Active comparator | 100mg/tablet, po, 4 tablets once daily for period I\&II D1(crossover) Receives: Drug: Glivec film coated tab 4T(400mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
Measured: 0-72hr
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
Measured: 0-72hr
Secondary outcomes (5)
Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)
Measured: 0-72hr
Evaluation of the safety of SYO-1126 and Glivec Film Coated 4T(400mg) from vital signs, physical exam, ECG, laboratory test, adverse events and so on.
Measured: 20~24 days
Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)
Measured: 0-72hr
Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)
Measured: 0-72hr
Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)
Measured: 0-72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Min Su Park, Doctor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504984
- Sponsor's protocol ID
- SYO1126
- Status last verified
- Jun 2012
- First submitted
- 27 Dec 2011
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01504984
- Acronym / sponsor ID
- SYO1126
- Conditions
- Healthy
- Keywords
- Evaluation of the pharmacokinetics equivalence, Healthy volunteers, Single dose over the period I and II(crossover), Healthy male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jan 2012 (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 purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.
Detailed description
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYO-1126 | Experimental | Drug: SYO-1126Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) |
| Glivec film coated tab 4T(400mg) | Active comparator | Drug: Glivec film coated tab 4T(400mg)100mg/tablet, po, 4 tablets once daily for period I\&II D1(crossover) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 20aged and 45aged in healthy males
- Over 55kg and BMI: 18.5~25 kg/m2
- Agreement with written informed consent
Key exclusion criteria (17 listed)
- Subject with symptoms of acute disease at the time of screening
- Clinically significant cardiovascular system, pulmonary system, renal system, endocrine system, blood system, gastrointestinal system, nervous system, mental disease or malignant tumor
- Subject with known for gastrointestinal disease or surgical history which affect on absorption of drug
- An impossible one who participates in clinical trial by result of screening tests
- Inadequate result of laboratory test AST/ALT > 1.5 x UNL Total bilirubin > 1.5 X UNL
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 |
|---|---|---|
| SYO-1126Also: Imatinib 400mgImatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover) | Drug | SYO-1126 |
| Glivec film coated tab 4T(400mg)Also: Imatinib 100mg, Glivec film coated tabImatinib 100mg/tablet, PO, 4 tablets once daily for period I\&II D1(crossover) | Drug | Glivec film coated tab 4T(400mg) |
Primary outcome
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
Time frame: 0-72hr
5 secondary outcomes
Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
Evaluation of the safety of SYO-1126 and Glivec Film Coated 4T(400mg) from vital signs, physical exam, ECG, laboratory test, adverse events and so on.
Time frame: 20~24 days
Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)
Time frame: 0-72hr
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 12 Jun 2012.
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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.
Min Su Park, Doctor principal investigator
Severance Hospital
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 SYO-1126 and Glivec film coated tab 4T(400mg) in people with Healthy, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
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 17 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 12 Jun 2012. 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 South Korea. 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?
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg) (time frame: 0-72hr). 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?
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 12 Jun 2012.