drugset / Trial / NCT03136185

Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)

NCT03136185

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (PK) and pharmacodynamics (PD) of a lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat (IMG-7289/MK-3543), administered orally once daily in participants with myelofibrosis. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera-myelofibrosis (PPVMF), and post-essential thrombocythaemia-myelofibrosis (PET-MF) (collectively referred to as 'MF'); inhibition of LSD1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.

Timeline

Start
2017-07-18
Primary completion
2022-03-08
Completion
2022-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bomedemstat Small molecule 0.25 mg/kg Oral
Subject Bomedemstat Small molecule 0.5 mg/kg Oral
Subject Bomedemstat Small molecule 0.6 mg/kg Oral