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Imatinib Mesylate

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

Ensayo de Inhibikase Therapeutics, Inc. en CML (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

64

previstos

Centros

1

Fin del objetivo primario

jun 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2022.

Qué mide

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)) (del registro, en inglés) (del dia 1 al dia 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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')

Más ensayos de IKT

Todos los de IKT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05623774), actualizada en nov 2025.