CMLPhase 1NCT05623774
A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg
A Phase 1 study testing Imatinib Mesylate and IkT-001Pro in people with CML, run by Inhibikase Therapeutics at 1 site in United States.
Trial summary
This study investigates the safety, tolerability and dose equivalence of drug IkT-001Pro in healthy volunteers (18 to 55 years old) in comparison to imatinib mesylate. This study is designed in 3 parts. Part A consists of 3 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- CML
- What is being tested?
- Imatinib Mesylate and IkT-001Pro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2022to 30 Dec 2024
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
- Healthy ambulatory male and female subjects > 18 to < 55 years of age at the Screening visit, with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
- Bodyweight > 50 kg and body mass index (BMI) > 18.0 and < 32.0 kg/m2 at the screening visit.
- Physical examination, clinical laboratory values, vital signs, and electrocardiogram (ECG) data. Vital signs and clinical laboratory values must be within the normal range and or deemed not clinically significant by the PI and ECG tracings must be normal at baseline and/or deemed not clinically significant by the PI.
- Female subjects must be postmenopausal, permanently sterile (bilateral tubal occlusion), or of childbearing potential with a negative pregnancy test, non-breastfeeding, and using two highly effective methods of birth control prior to screening and through completion of the last follow-up visit. If a subject discontinues early after receiving a dose of study drug, she must continue this method of birth control for at least 7 days following the last dose of the study drug. Highly effective methods of birth control are defined as follows: hormonal (ie, established use of oral, implantable, injectable, or transdermal hormonal methods of contraception); placement of an intrauterine device; placement of an intrauterine system; and mechanical /barrier method of contraception (ie, condom or occlusive cap [diaphragm or cervical/vault cap] in conjunction with spermicide [foam, gel, film, cream or suppository]).
- Male subjects must agree to practice an acceptable method of highly effective birth control from the Screening visit, while on study and for 7 days after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence; vasectomy; or a condom with spermicide (men) in combination with their partner's highly effective method.
- Males must be willing to abstain from sperm donation from the screening visit, while on study and through 30 days after receiving the last dose of study drug.
Who cannot join
- Any subject with previous exposure to imatinib or known hypersensitivity to imatinib.
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits. Abnormalities considered to be non-clinically significant by the Investigator are acceptable.
- Clinically significant abnormal physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits. NOTE: QTcF interval of > 450 msec in males or > 470 msec in females will be the basis for exclusion from the study. ECG may be repeated for confirmatory purposes if initial values obtained exceed the limits specified.
- Clinically significant abnormal renal function defined as a creatinine clearance rate < 90 mL/min
- Significant history (within six months prior to receiving the study drug) and/or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, endocrinological, hematological, dermatological, psychiatric, neurological, immunologic, ophthalmologic, metabolic, fluid retention and edema, bleeding disorders including hemorrhage or oncological disease.
- Any subject with a history, presence and/or current evidence of serologic positive result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1 or 2.
Show all 14Show fewer
- Recent history (within previous six months prior to screening) of alcohol or drug abuse (as judged by the investigator), or has consumed > 2 alcohol drinks/day during the last three months prior to screening (one glass is approximately equivalent to: beer [284 mL], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]). Subjects that consume three glasses of alcoholic beverages per day but less than 14 glasses per week may be enrolled at the discretion of the Investigator. Positive screens for alcohol or controlled substances at the screening or admission visits will disqualify a subject from study participation.
- Any subject who currently uses or has regularly used tobacco or tobacco-containing products (cigarettes, pipes, etc.) for at least 30 days prior to screening or positive urine cotinine screen (>300 ng/mL) at the screening or admission visits.
- Any subject who has received treatment with an investigational drug during the 30 days prior to screening. Exposure to an investigational medical device within 30 days of screening.
- Use of agents known to affect drug metabolism: use of any known CYP3A4 inducers and/or inhibitors or consumed grapefruit juice, grapefruit, Seville oranges or St John's Wort or products containing these within 14 days prior to first administration of study drug. Strong inducers of CYP3A4 include dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifampicin and phenobarbital. Strong inhibitors of CYP3A4 include ketoconazole, itroconazole, clarythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole.
- Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
- Any subject unwilling or unable to comply with study procedures.
- Pregnant or nursing women.
- Anyone who does not meet the requirements for exclusion of certain concomitant medications as defined in Section 7.5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Calibration and Dose Equivalence Pharmacokinetic Study in Healthy Volunteers Comparing IkT-001Pro to Imatinib Mesylate 400mg
This study investigates the safety, tolerability and dose equivalence of drug IkT-001Pro in healthy volunteers (18 to 55 years old) in comparison to imatinib mesylate. This study is designed in 3 parts.
Part A consists of 3 cohorts. In cohort 1 healthy participants will take a single, oral dose of 400mg IkT-001Pro then will be followed by a single dose of 400mg Imatinib mesylate after a 7-day washout. Cohort 2 and 3 will follow the same structure as cohort 1 with a different Ikt-001Pro dose.
Read more
Part B will be chosen using Part A data by statistical procedures. Part B will enroll 32 subjects to demonstrate the bioequivalence of IkT-001Pro (the 'Test') to 400 mg imatinib delivered as imatinib mesylase (the 'Reference').
Part C (Dose Equivalence at 600 mg):
Part C will enroll up to eight (8) subjects to demonstrate bioequivalence of imatinib delivered as 800 mg IkT-001Pro (the 'Test') to 600 mg imatinib delivered as imatinib mesylate ('the Reference')
Read the detailed description
Part A, Dose Calibration Cohort:
This is a crossover design dose calibration study in healthy volunteers to identify a dose of IkT-001Pro film-coated tablets that would be equivalent to imatinib free base 400 mg film-coated tablets containing imatinib mesylate.
Dose calibration cohorts will each consist of eight (8) subjects who will receive a single dose of IkT-001Pro at 400, 500 or 600 mg and then crossover to a single dose of imatinib 400 mg delivered as imatinib mesylate following a 7-day washout. The three cohorts will have staggered starting points. The 400 mg IkT-001Pro dose, washout and 400 mg imatinib delivered as imatinib mesylate will be completed first including full PK analysis. Following review of the PK data at 400 mg IkT-001Pro, the 500 mg and 600 mg cohorts will be enrolled approximately simultaneously.
Pharmacokinetic plasma samples for all three cohorts will be drawn pre-dose at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours after dosing. A 7-day washout period will take place between dosing of IkT-001Pro and dosing of 400 mg imatinib delivered as imatinib mesylate. PK plasma samples for the imatinib mesylate arm will be obtained on the same sampling schedule as the IkT-001Pro arm.
Part B- Dose Equivalence Cohort:
Part B will test the bioequivalence of the IkT-001Pro dose chosen in Part A. In this two-period crossover design dose equivalence study, up to 16 subjects will receive IkT-001Pro and up to 16 subjects will receive 400 mg imatinib as imatinib mesylate as a single dose. The dose of IkT-001Pro will be computed from the exposures measured in Part A to estimate the dose of IkT-001Pro that should be equivalent to 400 mg imatinib delivered as imatinib mesylate. After a 7-day washout period, the subjects that began on IkT-001Pro will switch to 400 mg imatinib delivered as imatinib mesylate. Similarly, the subjects that began on 400 mg imatinib delivered as imatinib mesylate will switch to the equivalent dose of IkT-001Pro. Blood samples for PK assessment will be drawn pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours after dosing for both IkT-001Pro and 400 mg imatinib.
Part C- Dose Equivalence at 600 mg:
Part C will test the single dose bioequivalence of imatinib free base delivered as the equivalent dose IkT-001Pro dose computed from Part A to single dose of imatinib delivered as 600 mg imatinib mesylate. Up to eight (8) subjects will be administered a single dose of 800 mg IkT-001Pro. After a 7-day washout period, the subjects will switch to 600 mg imatinib free base delivered as imatinib mesylate.
Blood samples for PK assessment will be drawn pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hrs post-dose on Day 1. The same sampling schedule will be followed for the IkT-001Pro and imatinib mesylate dosing periods.
General Methodological Considerations:
The Dose Calibration and Dose Equivalence cohorts will consist of up to 14 visits over a period of up to 28 days prior to dosing and 28 days after dosing. The dose-escalation pattern and timing for IkT-001Pro in Part A or Part B may be modified by the Safety Review Committee (SRC).
Subjects in each cohort of the study will be admitted to the unit approximately 24 hours prior to the expected time of dosing. They will be confined to the unit for approximately 96 hours in Part A and Part B of the study for each drug product to be administered. Subjects will not be confined to the unit during the wash-out period. No subject may be discharged from the unit until the investigator is satisfied that they have no continuing adverse events that could be related to study drug.
A full breakfast must be given no more than 60 mins prior to dosing in Parts A and B. The meal must be a high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal. The meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The caloric breakdown of the meal must be provided in the study report. The single dose of IkT-001Pro or 400 imatinib delivered as imatinib mesylate is to be taken after the meal with a large glass of water (240 ml or 8 oz).
- Conditions
- CML
- Being tested
- Imatinib Mesylate, IkT-001Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
400mg tablet
IkT-001ProDrug
100mg or 400mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Dose Calibration | Active comparator | In Part A, cohorts will consist of 8 subjects who will receive a single dose of Ikt-001Pro and then cross over to a single does of imatinib following a 7 day washout. Receives: Drug: Imatinib Mesylate; Drug: IkT-001Pro |
| Dose Equivalance | Active comparator | In Part B, up to 16 subjects will receive IkT001-Pro and up to 16 subjects will receive 400mg of imatinib mesylate. After a 7 day washout period the subjects will switch to receive the drug they did not previously receive. Receives: Drug: Imatinib Mesylate; Drug: IkT-001Pro |
| Dose Equivalence at 600 mg): | Active comparator | In Part C, up to eight (8) subjects will be administered a single dose of 800 mg IkT-001Pro. After a 7-day washout period, the subjects will switch to 600 mg imatinib. Receives: Drug: Imatinib Mesylate; Drug: IkT-001Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC(0-last))
Area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC0-last)
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by area under the concentration-time curve for imatinib from time zero to infinity (AUC0-inf)
Area under the concentration-time curve for imatinib from time zero to infinity (AUC(0-inf))
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by the maximum plasma concentration (Cmax) of imatinib
The maximum plasma concentration (Cmax) of imatinib
Measured: Day 1 through day 12
Safety: Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention
Incidence and temporal profile of treatment-emergent adverse events (TEAEs)
Measured: Day 1 through day 12
Safety: Proportion of those in each dosing cohort who discontinued the assigned regimen
Proportion of those in each dosing cohort who discontinued the assigned regimen
Measured: Day 1 through day 12
Secondary outcomes (6)
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for terminal rate constant
Measurement of lamda-z
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for terminal half-life
Measurement of terminal half-life t1/2
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for time to maximum concentration
Time to reach maximum concentration (tmax)
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose normalized maximum concentration
Dose-normalized maximum concentration Cmax/D, where D is the dose in mg
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose normalized area under the time concentration curve to last time point
Dose-normalized AUC(0-t)/D, where D is the dose in mg
Measured: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose-normalized area under the time concentration curve from 0 to infinite time
Dose-normalized AUC(0-infinity)/D, where D is the dose in mg.
Measured: Day 1 through day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start16 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMLStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a crossover design dose calibration study in healthy volunteers to identify a dose of IkT-001Pro film-coated tablets that would be equivalent to imatinib free base 400 mg film-coated tablets containing imatinib mesylate
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inhibikase Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Valentine, DO, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623774
- Sponsor's protocol ID
- IkT-001Pro-501
- Status last verified
- Nov 2025
- First submitted
- 9 Nov 2022
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Calibration and Dose Equivalence Pharmacokinetic Study in Healthy Volunteers Comparing IkT-001Pro to Imatinib Mesylate 400mg
- ClinicalTrials.gov ID
- NCT05623774
- Acronym / sponsor ID
- IkT-001Pro-501
- Conditions
- CML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Inhibikase TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- 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 investigates the safety, tolerability and dose equivalence of drug IkT-001Pro in healthy volunteers (18 to 55 years old) in comparison to imatinib mesylate. This study is designed in 3 parts.
Part A consists of 3 cohorts. In cohort 1 healthy participants will take a single, oral dose of 400mg IkT-001Pro then will be followed by a single dose of 400mg Imatinib mesylate after a 7-day washout. Cohort 2 and 3 will follow the same structure as cohort 1 with a different Ikt-001Pro dose.
Part B will be chosen using Part A data by statistical procedures. Part B will enroll 32 subjects to demonstrate the bioequivalence of IkT-001Pro (the 'Test') to 400 mg imatinib delivered as imatinib mesylase (the 'Reference').
Part C (Dose Equivalence at 600 mg):
Part C will enroll up to eight (8) subjects to demonstrate bioequivalence of imatinib delivered as 800 mg IkT-001Pro (the 'Test') to 600 mg imatinib delivered as imatinib mesylate ('the Reference')
Detailed description
Part A, Dose Calibration Cohort:
This is a crossover design dose calibration study in healthy volunteers to identify a dose of IkT-001Pro film-coated tablets that would be equivalent to imatinib free base 400 mg film-coated tablets containing imatinib mesylate.
Dose calibration cohorts will each consist of eight (8) subjects who will receive a single dose of IkT-001Pro at 400, 500 or 600 mg and then crossover to a single dose of imatinib 400 mg delivered as imatinib mesylate following a 7-day washout. The three cohorts will have staggered starting points. The 400 mg IkT-001Pro dose, washout and 400 mg imatinib delivered as imatinib mesylate will be completed first including full PK analysis. Following review of the PK data at 400 mg IkT-001Pro, the 500 mg and 600 mg cohorts will be enrolled approximately simultaneously.
Pharmacokinetic plasma samples for all three cohorts will be drawn pre-dose at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours after dosing. A 7-day washout period will take place between dosing of IkT-001Pro and dosing of 400 mg imatinib delivered as imatinib mesylate. PK plasma samples for the imatinib mesylate arm will be obtained on the same sampling schedule as the IkT-001Pro arm.
Part B- Dose Equivalence Cohort:
Part B will test the bioequivalence of the IkT-001Pro dose chosen in Part A. In this two-period crossover design dose equivalence study, up to 16 subjects will receive IkT-001Pro and up to 16 subjects will receive 400 mg imatinib as imatinib mesylate as a single dose. The dose of IkT-001Pro will be computed from the exposures measured in Part A to estimate the dose of IkT-001Pro that should be equivalent to 400 mg imatinib delivered as imatinib mesylate. After a 7-day washout period, the subjects that began on IkT-001Pro will switch to 400 mg imatinib delivered as imatinib mesylate. Similarly, the subjects that began on 400 mg imatinib delivered as imatinib mesylate will switch to the equivalent dose of IkT-001Pro. Blood samples for PK assessment will be drawn pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours after dosing for both IkT-001Pro and 400 mg imatinib.
Part C- Dose Equivalence at 600 mg:
Part C will test the single dose bioequivalence of imatinib free base delivered as the equivalent dose IkT-001Pro dose computed from Part A to single dose of imatinib delivered as 600 mg imatinib mesylate. Up to eight (8) subjects will be administered a single dose of 800 mg IkT-001Pro. After a 7-day washout period, the subjects will switch to 600 mg imatinib free base delivered as imatinib mesylate.
Blood samples for PK assessment will be drawn pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hrs post-dose on Day 1. The same sampling schedule will be followed for the IkT-001Pro and imatinib mesylate dosing periods.
General Methodological Considerations:
The Dose Calibration and Dose Equivalence cohorts will consist of up to 14 visits over a period of up to 28 days prior to dosing and 28 days after dosing. The dose-escalation pattern and timing for IkT-001Pro in Part A or Part B may be modified by the Safety Review Committee (SRC).
Subjects in each cohort of the study will be admitted to the unit approximately 24 hours prior to the expected time of dosing. They will be confined to the unit for approximately 96 hours in Part A and Part B of the study for each drug product to be administered. Subjects will not be confined to the unit during the wash-out period. No subject may be discharged from the unit until the investigator is satisfied that they have no continuing adverse events that could be related to study drug.
A full breakfast must be given no more than 60 mins prior to dosing in Parts A and B. The meal must be a high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal. The meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The caloric breakdown of the meal must be provided in the study report. The single dose of IkT-001Pro or 400 imatinib delivered as imatinib mesylate is to be taken after the meal with a large glass of water (240 ml or 8 oz).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a crossover design dose calibration study in healthy volunteers to identify a dose of IkT-001Pro film-coated tablets that would be equivalent to imatinib free base 400 mg film-coated tablets containing imatinib mesylate
| Arm | Type | Receives |
|---|---|---|
| Dose Calibration | Active comparator | Drug: Imatinib Mesylate, Drug: IkT-001ProIn Part A, cohorts will consist of 8 subjects who will receive a single dose of Ikt-001Pro and then cross over to a single does of imatinib following a 7 day washout. |
| Dose Equivalance | Active comparator | Drug: Imatinib Mesylate, Drug: IkT-001ProIn Part B, up to 16 subjects will receive IkT001-Pro and up to 16 subjects will receive 400mg of imatinib mesylate. After a 7 day washout period the subjects will switch to receive the drug they did not previously receive. |
| Dose Equivalence at 600 mg): | Active comparator | Drug: Imatinib Mesylate, Drug: IkT-001ProIn Part C, up to eight (8) subjects will be administered a single dose of 800 mg IkT-001Pro. After a 7-day washout period, the subjects will switch to 600 mg imatinib. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
- Healthy ambulatory male and female subjects > 18 to < 55 years of age at the Screening visit, with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
- Bodyweight > 50 kg and body mass index (BMI) > 18.0 and < 32.0 kg/m2 at the screening visit.
- Physical examination, clinical laboratory values, vital signs, and electrocardiogram (ECG) data. Vital signs and clinical laboratory values must be within the normal range and or deemed not clinically significant by the PI and ECG tracings must be normal at baseline and/or deemed not clinically significant by the PI.
- Female subjects must be postmenopausal, permanently sterile (bilateral tubal occlusion), or of childbearing potential with a negative pregnancy test, non-breastfeeding, and using two highly effective methods of birth control prior to screening and through completion of the last follow-up visit. If a subject discontinues early after receiving a dose of study drug, she must continue this method of birth control for at least 7 days following the last dose of the study drug. Highly effective methods of birth control are defined as follows: hormonal (ie, established use of oral, implantable, injectable, or transdermal hormonal methods of contraception); placement of an intrauterine device; placement of an intrauterine system; and mechanical /barrier method of contraception (ie, condom or occlusive cap [diaphragm or cervical/vault cap] in conjunction with spermicide [foam, gel, film, cream or suppository]).
Key exclusion criteria (14 listed)
- Any subject with previous exposure to imatinib or known hypersensitivity to imatinib.
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits. Abnormalities considered to be non-clinically significant by the Investigator are acceptable.
- Clinically significant abnormal physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits. NOTE: QTcF interval of > 450 msec in males or > 470 msec in females will be the basis for exclusion from the study. ECG may be repeated for confirmatory purposes if initial values obtained exceed the limits specified.
- Clinically significant abnormal renal function defined as a creatinine clearance rate < 90 mL/min
- Significant history (within six months prior to receiving the study drug) and/or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, endocrinological, hematological, dermatological, psychiatric, neurological, immunologic, ophthalmologic, metabolic, fluid retention and edema, bleeding disorders including hemorrhage or oncological disease.
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 Mesylate400mg tablet | Drug | Dose Calibration, Dose Equivalance, Dose Equivalence at 600 mg): |
| IkT-001Pro100mg or 400mg tablet | Drug | Dose Calibration, Dose Equivalance, Dose Equivalence at 600 mg): |
Primary outcome
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC(0-last))
Time frame: Day 1 through day 12
Area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC0-last)
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by area under the concentration-time curve for imatinib from time zero to infinity (AUC0-inf)
Time frame: Day 1 through day 12
Area under the concentration-time curve for imatinib from time zero to infinity (AUC(0-inf))
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by the maximum plasma concentration (Cmax) of imatinib
Time frame: Day 1 through day 12
The maximum plasma concentration (Cmax) of imatinib
Safety: Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention
Time frame: Day 1 through day 12
Incidence and temporal profile of treatment-emergent adverse events (TEAEs)
Safety: Proportion of those in each dosing cohort who discontinued the assigned regimen
Time frame: Day 1 through day 12
Proportion of those in each dosing cohort who discontinued the assigned regimen
6 secondary outcomes
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for terminal rate constant
Time frame: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for terminal half-life
Time frame: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for time to maximum concentration
Time frame: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose normalized maximum concentration
Time frame: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose normalized area under the time concentration curve to last time point
Time frame: Day 1 through day 12
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose-normalized area under the time concentration curve from 0 to infinite time
Time frame: Day 1 through day 12
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 6 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for CML
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 1
Allogeneic iNKT Cell Therapy (agenT-797) After SCT
Allogenic Stem Cell Transplantation, Myeloid Malignancies
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
RecruitingPhase 1
Prophylactic DLI-X for Leukemia Relapse After HCT
Acute Lymphoid Leukemia, Acute Myeloid Leukemia
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.
Michelle Valentine, DO principal investigator
Celerion
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 and IkT-001Pro in people with CML, run by Inhibikase Therapeutics at 1 site in United States.
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 7 inclusion and 14 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 6 Nov 2025. 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 United States. 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?
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC(0-last)) (time frame: Day 1 through day 12). The study lists 5 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 6 Nov 2025.