Chronic Myeloid LeukemiaPhase 1NCT01751919
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
A Phase 1 study testing Imatinib mesylate tablet 400 mg, 1 Tablet and Glivec film-coated tablet 100 mg, 4 Tablets in people with Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
1. Investigational Product 1. Imatinib mesylate tablet 400 mg 2. Glivec film-coated tablet 100 mg (Comparator) 2. Expected target disease 1. chronic myeloid leukemia 2. Gastrointestinal stromal tumors 3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study 1. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
- What is being tested?
- Imatinib mesylate tablet 400 mg, 1 Tablet and Glivec film-coated tablet 100 mg, 4 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Aug 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteers between the ages of 20 to 50 years old
- weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
- having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- doctor determines to be suitable as subjects within 3 weeks ago before administration
Who cannot join
- Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
- Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
- Creatinine clearance < 80 mL/min
- Gastrointestinal diseases or surgeries that affect absorption of drug
- Excessive drinking(exceed 21units/week)
- Smoking over 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)
- Investigational Product
- Imatinib mesylate tablet 400 mg
- Glivec film-coated tablet 100 mg (Comparator)
- Expected target disease
- chronic myeloid leukemia
- Gastrointestinal stromal tumors
- Study design : Randomized, open-label, single dose, two-period, two-way, crossover study
- 36 healthy subjects, 2 groups (18 subjects/group)
- 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
- wash-out period : 14 days
- Evaluation on pharmacokinetics(PKs) and safety
- PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
- safety : adverse events, physical examination, vital sign, ECG, Laboratory test
- Statistical method
- Demography Characteristics
- Pharmacokinetic parameters
- Safety data
- Being tested
- Imatinib mesylate tablet 400 mg, 1 Tablet, Glivec film-coated tablet 100 mg, 4 Tablets
- Keywords
- CML, GIST
- 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.
Imatinib mesylate tablet 400 mg, 1 TabletDrug
Glivec film-coated tablet 100 mg, 4 TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (RT) | Other | * Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator)
* Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) Receives: Drug: Imatinib mesylate tablet 400 mg, 1 Tablet; Drug: Glivec film-coated tablet 100 mg, 4 Tablets |
| Group 2 (TR) | Other | * Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental)
* Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) Receives: Drug: Imatinib mesylate tablet 400 mg, 1 Tablet; Drug: Glivec film-coated tablet 100 mg, 4 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration in plasma (Cmax) of Imatinib mesylate
Measured: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate
Measured: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Secondary outcomes (3)
Time to Cmax (Tmax) of Imatinib mesylate
Measured: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate
Measured: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Terminal Elimination Half-life (t1/2) of Imatinib mesylate
Measured: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751919
- Sponsor's protocol ID
- Imatinib_CML_I
- Status last verified
- Sep 2014
- First submitted
- 14 Dec 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodriguez P, Marquez S, Guarneri C, Estevez-Parrillo FT, Laurenz M, Estevez-Carrizo FE. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clin Ther. 2009 Oct;31(10):2224-32. doi: 10.1016/j.clinthera.2009.10.009.
PubMed 19922893Nikolova Z, Peng B, Hubert M, Sieberling M, Keller U, Ho YY, Schran H, Capdeville R. Bioequivalence, safety, and tolerability of imatinib tablets compared with capsules. Cancer Chemother Pharmacol. 2004 May;53(5):433-8. doi: 10.1007/s00280-003-0756-z.
PubMed 15132131
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400 mg (1 Tablet) and Glivec Film-coated Tablet 100 mg (4 Tablets) After Oral Administration in Healthy Male Subjects (Phase I)
- ClinicalTrials.gov ID
- NCT01751919
- Acronym / sponsor ID
- Imatinib_CML_I
- Keywords
- CML, GIST
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Dec 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.
- Investigational Product
- Imatinib mesylate tablet 400 mg
- Glivec film-coated tablet 100 mg (Comparator)
- Expected target disease
- chronic myeloid leukemia
- Gastrointestinal stromal tumors
- Study design : Randomized, open-label, single dose, two-period, two-way, crossover study
- 36 healthy subjects, 2 groups (18 subjects/group)
- 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
- wash-out period : 14 days
- Evaluation on pharmacokinetics(PKs) and safety
- PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
- safety : adverse events, physical examination, vital sign, ECG, Laboratory test
- Statistical method
- Demography Characteristics
- Pharmacokinetic parameters
- Safety data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (RT) | Other | Drug: Imatinib mesylate tablet 400 mg, 1 Tablet, Drug: Glivec film-coated tablet 100 mg, 4 Tablets* Period 1: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) * Period 2: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) |
| Group 2 (TR) | Other | Drug: Imatinib mesylate tablet 400 mg, 1 Tablet, Drug: Glivec film-coated tablet 100 mg, 4 Tablets* Period 1: Imatinib mesylate tablet 400 mg, 1 tablet (experimental) * Period 2: Glivec film-coated tablet 100 mg, 4 tablets (Active comparator) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male volunteers between the ages of 20 to 50 years old
- weight more than 55kg and within the range of ±20% of ideal body weight (IBW)
- having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- doctor determines to be suitable as subjects within 3 weeks ago before administration
Key exclusion criteria (6 listed)
- Hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate
- Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
- Creatinine clearance < 80 mL/min
- Gastrointestinal diseases or surgeries that affect absorption of drug
- Excessive drinking(exceed 21units/week)
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 |
|---|---|---|
| Imatinib mesylate tablet 400 mg, 1 Tablet | Drug | Group 1 (RT), Group 2 (TR) |
| Glivec film-coated tablet 100 mg, 4 Tablets | Drug | Group 1 (RT), Group 2 (TR) |
Primary outcome
Maximum concentration in plasma (Cmax) of Imatinib mesylate
Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Area under the plasma concentration-time curve from zero time until the last measurable concentration (AUClast) of Imatinib mesylate
Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
3 secondary outcomes
Time to Cmax (Tmax) of Imatinib mesylate
Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of Imatinib mesylate
Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
Terminal Elimination Half-life (t1/2) of Imatinib mesylate
Time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose
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 1 Oct 2014.
- Background: PubMed 19922893Parrillo-Campiglia S, Ercoli MC, Umpierrez O, Rodriguez P, Marquez S, Guarneri C, Estevez-Parrillo FT, Laurenz M, Estevez-Carrizo FE. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers. Clin Ther. 2009 Oct;31(10):2224-32. doi: 10.1016/j.clinthera.2009.10.009.
- Background: PubMed 15132131Nikolova Z, Peng B, Hubert M, Sieberling M, Keller U, Ho YY, Schran H, Capdeville R. Bioequivalence, safety, and tolerability of imatinib tablets compared with capsules. Cancer Chemother Pharmacol. 2004 May;53(5):433-8. doi: 10.1007/s00280-003-0756-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Imatinib mesylate tablet 400 mg, 1 Tablet and Glivec film-coated tablet 100 mg, 4 Tablets in people with Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor, run by Dong-A ST Co., Ltd. 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 4 inclusion and 6 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 1 Oct 2014. 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?
Maximum concentration in plasma (Cmax) of Imatinib mesylate (time frame: Pre-dose(0h) AND 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 h post-dose). 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 NCT01751919, which also lists 2 linked publications.
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 1 Oct 2014.