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.
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Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Up to Day 7 of the ITP
Number of Participants With Serious Adverse Events
Timeframe: Up to approximately 30 months
Number of Participants With Adverse Events
Timeframe: Up to approximately 30 months
Number of Participants That Discontinued Study Treatment Due To AEs
Timeframe: Up to approximately 29 months
Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat
Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat
Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24)
Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration
Timeframe: Day 21: Pre-dose and 0.5, 1, 2, 3, 4, 8, and 24 hours (Day 22) after dosing.
Percentage Change From Baseline in Spleen Volume
Timeframe: Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), and ATP1 Day 168 (Study Day 337)
Percentage Change From Baseline in Spleen Size
Timeframe: Baseline, ITP Day 84 (Study Day 84), ITP Day 168 (Study Day 168), ATP1 Day 84 (Study Day 253), ATP1 Day 168 (Study Day 337), ATP2 Day 84 (Study Day 422), ATP2 Day 168 (Study Day 506), and ATP3 Day 84 (Study Day 591)