Non-obstructive Hypertrophic Cardiomyopathy
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability, and potential efficacy of IMB-1018972 in patients with non-obstructive HCM.
Interventions
DRUGIMB-1018972
Modified release (MR) oral tablet
DRUGPlacebo
Matching oral tablet
Sponsors
Imbria Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European guidelines * Ability to perform an upright treadmill cardiopulmonary exercise test * Agreement to abide by contraceptive requirements
Exclusion criteria
* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability * Women who are pregnant, planning to become pregnant or lactating * Participation in another clinical study involving a test product or invasive medical device within 28 days (or within 5 elimination half-lives of the respective test product, whichever is longer), prior to first dosing
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
United Kingdom, United States
Outcome results
None listed