Trials / Completed
CompletedNCT03136185
Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study initiated as a Phase 1/2a study assessing the safety of the starting dose, an 85-day duration of treatment, and the PK and PD effects of bomedemstat, with transition to a Phase 2b study incorporating changes supported by the Phase 1/2a data.
Conditions
- Myelofibrosis
- Post-polycythemia Vera Myelofibrosis (PPV-MF)
- Post-essential Thrombocythemia Myelofibrosis (PET-MF)
- Primary Myelofibrosis (PMF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bomedemstat | Oral (capsule) administration according to dose allocation. |
Timeline
- Start date
- 2017-07-18
- Primary completion
- 2022-03-08
- Completion
- 2022-03-08
- First posted
- 2017-05-02
- Last updated
- 2024-01-10
- Results posted
- 2024-01-10
Locations
5 sites across 5 countries: United States, Australia, Germany, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03136185. Inclusion in this directory is not an endorsement.