obstructive hypertrophic cardiomyopathy (oHCM) MedDRA version: 20.0 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Code: CK-3773274
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CK-3773274
Current Sponsor code: CK-3773274
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DI
Sponsors
Cytokinetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions for the duration specified in the Schedule of Activities (SoA). Males and females between 18 and 85 years of age at Screening. Body weight is =45 kg at Screening. Diagnosed with oHCM per the following criteria: • Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease. • Has minimal wall thickness =15 mm at time of initial diagnosis (minimal wall thickness =13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation). Adequate acoustic windows for echocardiography. Has LVOT-G during screening as follows: • Resting gradient =50 mmHg OR • Resting gradient =30 mmHg and 4 weeks prior to Randomization and anticipate remaining on the same medication regimen during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - Aortic stenosis or fixed subaortic obstruction. - Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis). - History of LV systolic dysfunction (LVEF 70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction. - Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the study period. - Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. - Paroxysmal atrial fibrillation or flutter documented during the Screening period. - Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) =6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.) - History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening. - Has received prior treatment with CK3773274 or is currently receiving mavacamten.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of CK3773274 in patients with symptomatic oHCM;Secondary Objective: To describe the concentration-response relationship of CK3773274 on the resting and post-Valsalva LVOT-G on echocardiogram over 10 weeks of treatment. To describe the dose response relationship of CK3773274 in patients with symptomatic oHCM. To evaluate the plasma concentrations of CK3773274 in patients with oHCM.;Primary end point(s): • Patient incidence of reported AEs • Patient incidence of reported SAEs • Patient incidence of LVEF < 50% ;Timepoint(s) of evaluation of this end point: Week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The slope of the relationship of the plasma concentration of CK3773274 to the change from baseline in the resting LVOT-G • The slope of the relationship of the plasma concentration of CK3773274 to the change from baseline in the post-Valsalva LVOT-G • The change from baseline in resting and post-Valsalva LVOT-G over time as a function of dose • The change from baseline in resting and post-Valsalva LVOT-G to Week 10 • Observed maximum plasma concentration (Cmax) and trough plasma concentration (Ctrough) for CK-3773274 ;Timepoint(s) of evaluation of this end point: Week 10 | — |
Countries
Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactMedical Affairs
Cytokinetics Inc
Outcome results
None listed