A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg
- Conditions
- CML
- Registration Number
- NCT05623774
- Lead Sponsor
- Inhibikase Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria:<br><br> 1. Subject must have all questions about the study answered and must have signed the<br> informed consent document before any study-specific procedures are performed.<br><br> 2. Healthy ambulatory male and female subjects > 18 to < 55 years of age at the<br> Screening visit, with no history or evidence of clinically relevant medical<br> disorders as determined by the Investigator in consultation with the Sponsor.<br><br> 3. Bodyweight > 50 kg and body mass index (BMI) > 18.0 and < 32.0 kg/m2 at the<br> screening visit.<br><br> 4. Physical examination, clinical laboratory values, vital signs, and electrocardiogram<br> (ECG) data. Vital signs and clinical laboratory values must be within the normal<br> range and or deemed not clinically significant by the PI and ECG tracings must be<br> normal at baseline and/or deemed not clinically significant by the PI.<br><br> 5. Female subjects must be postmenopausal, permanently sterile (bilateral tubal<br> occlusion), or of childbearing potential with a negative pregnancy test,<br> non-breastfeeding, and using two highly effective methods of birth control prior to<br> screening and through completion of the last follow-up visit. If a subject<br> discontinues early after receiving a dose of study drug, she must continue this<br> method of birth control for at least 7 days following the last dose of the study<br> drug. Highly effective methods of birth control are defined as follows: hormonal<br> (ie, established use of oral, implantable, injectable, or transdermal hormonal<br> methods of contraception); placement of an intrauterine device; placement of an<br> intrauterine system; and mechanical /barrier method of contraception (ie, condom or<br> occlusive cap [diaphragm or cervical/vault cap] in conjunction with spermicide<br> [foam, gel, film, cream or suppository]).<br><br> 6. Male subjects must agree to practice an acceptable method of highly effective birth<br> control from the Screening visit, while on study and for 7 days after receiving the<br> last dose of study drug. Highly effective methods of birth control include sexual<br> abstinence; vasectomy; or a condom with spermicide (men) in combination with their<br> partner's highly effective method.<br><br> 7. Males must be willing to abstain from sperm donation from the screening visit, while<br> on study and through 30 days after receiving the last dose of study drug.<br><br>Exclusion Criteria:<br><br> 1. Any subject with previous exposure to imatinib or known hypersensitivity to<br> imatinib.<br><br> 2. Clinically significant abnormal values for hematology, clinical chemistry or<br> urinalysis at the screening and admission visits. Abnormalities considered to be<br> non-clinically significant by the Investigator are acceptable.<br><br> 3. Clinically significant abnormal physical examination or 12-lead electrocardiogram<br> (ECG) at the screening or admission visits. NOTE: QTcF interval of > 450 msec in<br> males or > 470 msec in females will be the basis for exclusion from the study. ECG<br> may be repeated for confirmatory purposes if initial values obtained exceed the<br> limits specified.<br><br> 4. Clinically significant abnormal renal function defined as a creatinine clearance<br> rate < 90 mL/min<br><br> 5. Significant history (within six months prior to receiving the study drug) and/or<br> presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal,<br> endocrinological, hematological, dermatological, psychiatric, neurological,<br> immunologic, ophthalmologic, metabolic, fluid retention and edema, bleeding<br> disorders including hemorrhage or oncological disease.<br><br> 6. Any subject with a history, presence and/or current evidence of serologic positive<br> result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1<br> or 2.<br><br> 7. Recent history (within previous six months prior to screening) of alcohol or drug<br> abuse (as judged by the investigator), or has consumed > 2 alcohol drinks/day during<br> the last three months prior to screening (one glass is approximately equivalent to:<br> beer [284 mL], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]).<br> Subjects that consume three glasses of alcoholic beverages per day but less than 14<br> glasses per week may be enrolled at the discretion of the Investigator. Positive<br> screens for alcohol or controlled substances at the screening or admission visits<br> will disqualify a subject from study participation.<br><br> 8. Any subject who currently uses or has regularly used tobacco or tobacco-containing<br> products (cigarettes, pipes, etc.) for at least 30 days prior to screening or<br> positive urine cotinine screen (>300 ng/mL) at the screening or admission visits.<br><br> 9. Any subject who has received treatment with an investigational drug during the 30<br> days prior to screening. Exposure to an investigational medical device within 30<br> days of screening.<br><br> 10. Use of agents known to affect drug metabolism: use of any known CYP3A4 inducers<br> and/or inhibitors or consumed grapefruit juice, grapefruit, Seville oranges or St<br> John's Wort or products containing these within 14 days prior to first<br> administration of study drug. Strong inducers of CYP3A4 include dexamethasone,<br> phenytoin, carbamazepine, rifampin, rifabutin, rifampicin and phenobarbital. Strong<br> inhibitors of CYP3A4 include ketoconazole, itroconazole, clarythromycin, atazanavir,<br> indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and<br> voriconazole.<br><br> 11. Investigative site personnel or their immediate families (spouse, parent, child or<br> sibling whether biological or legally adopted).<br><br> 12. Any subject unwilling or unable to comply with study procedures.<br><br> 13. Pregnant or nursing women.<br><br> 14. Anyone who does not meet the requirements for exclusion of certain concomitant<br> medications as defined in Section 7.5.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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));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);Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by 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;Safety: Proportion of those in each dosing cohort who discontinued the assigned regimen
- Secondary Outcome Measures
Name Time Method