A Dose Calibration Study Comparing IkT-001Pro to Imatinib Mesylate 400mg
Status:
Recruiting
Trial end date:
2023-05-20
Target enrollment:
Participant gender:
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 2 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').