A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg

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. 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')

Timeline

Start

2022-12-16

Primary completion

2024-06-30

Completion

2024-12-30

Drugs

Indications