Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05623774 | A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg | PHASE1 | COMPLETED | 64 | — | — | Dec 16, 2022 | Dec 30, 2024 | Nov 6, 2025 | 1 | United States |
Area under the concentration-time curve for imatinib from time zero to last measurable concentration (AUC0-last)
Area under the concentration-time curve for imatinib from time zero to infinity (AUC(0-inf))
The maximum plasma concentration (Cmax) of imatinib
Incidence and temporal profile of treatment-emergent adverse events (TEAEs)
Proportion of those in each dosing cohort who discontinued the assigned regimen
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Imatinib Mesylate | DRUG | 400mg tablet |
| IkT-001Pro | DRUG | 100mg or 400mg tablet |
Inclusion Criteria: 1. Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed. 2. Healthy ambulatory male and female subjects \> 18 to \< 55 years of age at the Screening visit, with no history o...