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The purpose of this study is to assess the safety, tolerability, and potential efficacy of IMB-1018972 in patients with non-obstructive HCM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMB-1018972 200mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMB-1018972 | Drug | Modified release (MR) oral tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline through Week 14 Safety Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET) | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Imbria Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imbria Investigational Site | La Jolla | California | 92093 | United States | ||
| Imbria Investigational Site |
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| Placebo |
| Drug |
Matching oral tablet |
|
| Los Angeles |
| California |
| 90048 |
| United States |
| Imbria Investigational Site | San Francisco | California | 94143 | United States |
| Imbria Investigational Site | Chicago | Illinois | 60611 | United States |
| Imbria Investigational Site | Boston | Massachusetts | 02111 | United States |
| Imbria Investigational Site | Burlington | Massachusetts | 01805 | United States |
| Imbria Investigational Site | St Louis | Missouri | 63110 | United States |
| Imbria Investigational Site | Morristown | New Jersey | 07960 | United States |
| Imbria Investigational Site | New York | New York | 10016 | United States |
| Imbria Investigational Site | Charlotte | North Carolina | 28203 | United States |
| Imbria Investigational Site | Portland | Oregon | 97239 | United States |
| Imbria Investigational Site | Houston | Texas | 77030 | United States |
| Imbria Investigational Site | Salt Lake City | Utah | 84112 | United States |
| Imbria Investigational Site | Oxford | United Kingdom |