← Back to Search

Tyrosine Kinase Inhibitor

IkT-001Pro vs Imatinib for Chronic Myeloid Leukemia

Phase 1
Recruiting
Led By Janelle Weyer, MD
Research Sponsored by Inhibikase Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bodyweight must be > 50 kg and body mass index (BMI) must be > 18.0 and < 32.0 kg/m2 at the screening visit.
Male subjects must agree to practice an acceptable method of highly effective birth control.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 12
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new drug, IkT-001Pro, compared to imatinib mesylate in healthy volunteers. Data from Part A will be used to select Part B which will assess bioequivalence.

Who is the study for?
Healthy adults aged 18-55, with a BMI of 18.0-32.0 kg/m2, can join this trial if they don't smoke or use tobacco and haven't used any investigational drugs in the last month. Women must not be pregnant/nursing and should use effective birth control; men must also agree to use contraception.Check my eligibility
What is being tested?
The study is testing IkT-001Pro against Imatinib Mesylate (400mg) for safety, tolerability, and dose equivalence in healthy volunteers. It's split into two parts: Part A has three cohorts taking different doses followed by Imatinib after a washout period; Part B will test bioequivalence based on Part A results.See study design
What are the potential side effects?
While specific side effects are not listed for IkT-001Pro as it's under investigation, similar medications may cause digestive issues, muscle cramps, rash, fatigue, joint pain or swelling. Close monitoring during the trial helps identify any potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is over 50 kg and my BMI is between 18.0 and 32.0.
Select...
I agree to use a highly effective method of birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 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 the maximum plasma concentration (Cmax) of imatinib
+2 more
Secondary outcome measures
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
Exposure of imatinib after administration of IkT-001Pro and imatinib mesylate, as measured by imatinib pharmacokinetic parameters for dose normalized maximum concentration
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
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Dose CalibrationActive Control2 Interventions
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.
Group II: Dose EquivalanceActive Control2 Interventions
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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Inhibikase Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
221 Total Patients Enrolled
Janelle Weyer, MDPrincipal InvestigatorCelerion

Media Library

IkT-001Pro (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05623774 — Phase 1
Chronic Myeloid Leukemia Research Study Groups: Dose Calibration, Dose Equivalance
Chronic Myeloid Leukemia Clinical Trial 2023: IkT-001Pro Highlights & Side Effects. Trial Name: NCT05623774 — Phase 1
IkT-001Pro (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623774 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intent behind this clinical experiment?

"This medical trial, which will run from day 1 to 12, is intended to measure the proportion of patients who drop out in each dosing cohort. Secondary objectives include assessing imatinib exposure after administration via IkT-001Pro and mesylate through peak concentration (Cmax/D), time it takes for maximal concentration (tmax) and terminal half life (t1/2)."

Answered by AI

Does this research permit elderly individuals to participate?

"This clinical trial stipulates that participants must be at least 18 years old and no older than 55."

Answered by AI

How many participants are taking part in this research endeavor?

"Affirmative. According to information found on clinicaltrials.gov, this research endeavour is still recruiting participants after its initial listing date of November 30th 2022; the entry was most recently edited on the 21st of November 2022. The study requires 64 patients from 1 medical centre."

Answered by AI

Are there openings to participate in this research initiative at present?

"According to clinicaltrials.gov, this trial is still recruiting participants and was initially announced on November 30th 2022 with a recent update occurring on the 21st of that same month."

Answered by AI

Has Dose Calibration obtained sanction from the FDA?

"Due to the lack of data surrounding safety and efficacy, we have rated Dose Calibration as a 1 on our scale from 1-3."

Answered by AI

What qualifications must prospective participants have to be considered for this experiment?

"For this medical trial, 64 adults aged 18 to 55 with chronic myeloid leukemia are being sought. To be eligible, they must have answered all questions and signed a consent form prior to any procedures, weigh more than 50 kgs with a BMI between 18.0 and 32.0kg/m2 at the screening visit; display normal physical examination values as well as vital signs and clinical laboratory results deemed non-clinically significant by the PI; male participants should agree to use highly effective birth control for seven days after receiving their last dose of study drug or abstain from sperm donation during that period while female participants must either be"

Answered by AI
~28 spots leftby Mar 2025