Chronic Myeloid LeukemiaPhase 1ImatinibNCT01270984
Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
A Phase 1 study testing Luckyvec 400mg film coated tablet and Glivec 100mg film coated tablet in people with Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumors, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy 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
- Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors
- What is being tested?
- Luckyvec 400mg film coated tablet and Glivec 100mg film coated tablet
- 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
- Nov 2010to Dec 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20 aged and 45 aged in healthy males
- BMI: 18~29.9 kg/m2, (BMI = (체중 [kg])/(height [m])2)
- Agreement with written informed consent
Who cannot join
- Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, gastrointestinal system, immune system, skin system, nervous system or mental disease(Past history or present)
- Subject with symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject with known for history which affect on the ADME of drug
- Clinically significant active chronic disease
- Inadequate result of laboratory test
- AST/ALT > 1.5 x UNL
Show all 18Show fewer
- Total bilirubin > 1.5 x UNL
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
- Taking ETC(ethical the counter)medicine within 14 days
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease(Except for mild allergic rhinitis and dermatits seems to be not need for medication)
- Subject with known for hypersensitivity reaction to imatinib analog
- Not able to taking the institutional standard meal
- Previously make whole blood donation within 60 days or component blood donation within 20 days
- Previously have blood transfusion within 30 days
- Previously participated in other trial within 30 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy volunteers.
Read the detailed description
Healthy volunteers are administrated single-dose over the period I and II (Crossover) of Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg.
Every time before and after each medication, PK parameters and safety of Luckyvec 400mg tablet and Glivec 100mg is performed using a blood sample and conducting some tests(Laboratory test, V/S, Physical Examination, etc) respectively.
- Being tested
- Luckyvec 400mg film coated tablet, Glivec 100mg film coated tablet
- Keywords
- Imatinib mesylate, Pharmacokinetics, Healthy volunteers
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luckyvec 400mg film coated tabletDrug
Also called Luckyvec
•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover)
Glivec 100mg film coated tabletDrug
Also called Glivec
•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover)
| Study group | Role | What they receive |
|---|---|---|
| Luckyvec 400mg film coated tablet | Experimental | 400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover) Receives: Drug: Luckyvec 400mg film coated tablet |
| Glivec 100mg film coated tablet | Active comparator | 100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover) Receives: Drug: Glivec 100mg film coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
Measured: 0-72hr
Secondary outcomes (1)
To evaluate the safety of Luckyvec 400mg tablet and Glivec 100mg tablet from vital signs, physical exam, ECG, laboratory test, adverse event and so on.
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 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
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 Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji-Young Park, Principal investigator, jypark21@korea.ac.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270984
- Sponsor's protocol ID
- 131HPS10D
- Acronym
- Imatinib
- Status last verified
- Oct 2012
- First submitted
- 4 Jan 2011
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KA, Park SJ, Kim C, Park JY. Single-dose, randomized crossover comparisons of different-strength imatinib mesylate formulations in healthy Korean male subjects. Clin Ther. 2013 Oct;35(10):1595-602. doi: 10.1016/j.clinthera.2013.08.008. Epub 2013 Sep 21.
PubMed 24060561
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01270984
- Acronym / sponsor ID
- Imatinib / 131HPS10D
- Keywords
- Imatinib mesylate, Pharmacokinetics, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jan 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 purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when administered a single-dose to healthy volunteers.
Detailed description
Healthy volunteers are administrated single-dose over the period I and II (Crossover) of Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg.
Every time before and after each medication, PK parameters and safety of Luckyvec 400mg tablet and Glivec 100mg is performed using a blood sample and conducting some tests(Laboratory test, V/S, Physical Examination, etc) respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luckyvec 400mg film coated tablet | Experimental | Drug: Luckyvec 400mg film coated tablet400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover) |
| Glivec 100mg film coated tablet | Active comparator | Drug: Glivec 100mg film coated tablet100mg/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 20 aged and 45 aged in healthy males
- BMI: 18~29.9 kg/m2, (BMI = (체중 [kg])/(height [m])2)
- Agreement with written informed consent
Key exclusion criteria (18 listed)
- Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, gastrointestinal system, immune system, skin system, nervous system or mental disease(Past history or present)
- Subject with symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject with known for history which affect on the ADME of drug
- Clinically significant active chronic disease
- Inadequate result of laboratory test
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 |
|---|---|---|
| Luckyvec 400mg film coated tabletAlso: Luckyvec•400mg/tablet, PO, 1 tablet once daily for Period I \& II D1(crossover) | Drug | Luckyvec 400mg film coated tablet |
| Glivec 100mg film coated tabletAlso: Glivec•100mg/tablet, PO, 4 tablets once daily for Period I \& II D1(crossover) | Drug | Glivec 100mg film coated tablet |
Primary outcome
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects
Time frame: 0-72hr
1 secondary outcome
To evaluate the safety of Luckyvec 400mg tablet and Glivec 100mg tablet from vital signs, physical exam, ECG, laboratory test, adverse event and so on.
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 31 Oct 2012.
- Derived from this study: PubMed 24060561Kim KA, Park SJ, Kim C, Park JY. Single-dose, randomized crossover comparisons of different-strength imatinib mesylate formulations in healthy Korean male subjects. Clin Ther. 2013 Oct;35(10):1595-602. doi: 10.1016/j.clinthera.2013.08.008. Epub 2013 Sep 21.
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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.
Ji-Young Park principal investigator
jypark21@korea.ac.kr
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 Luckyvec 400mg film coated tablet and Glivec 100mg film coated tablet in people with Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumors, run by Chong Kun Dang Pharmaceutical 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 18 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 31 Oct 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?
To evaluate the pharmacokinetics of Luckyvec 400mg tablet and Glivec 100mg tablet in healthy subjects (time frame: 0-72hr). 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 NCT01270984, 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 31 Oct 2012.