The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Modified release (MR) oral tablet
Matching oral tablet
Imbria Investigational Site
Aarhus, Denmark
Imbria Investigational Site
Turku, Finland
Imbria Investigational Site
Uppsala, Sweden
Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
Time frame: Randomization through Week 10 Safety Follow-up
Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET
Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF \<1.7 ml/g/min
Time frame: Baseline through Week 8
Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET
Time frame: Baseline through Week 8
Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET
Time frame: Baseline through Week 8
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