Dose-finding Study to Evaluate the Safety, Tolerability, PK, and PD of CK-3773274 in Adults With HCM
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Interventions
- Drug: CK-3773274 (5 - 15 mg)Drug: CK-3773274 (10 - 30 mg)Drug: Placebo for CK-3773274
- Registration Number
- NCT04219826
- Lead Sponsor
- Cytokinetics
- Brief Summary
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CK-3773274 - Cohort 1 (Obstructive HCM) CK-3773274 (5 - 15 mg) Subjects will receive doses of 5 - 15 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 - Cohort 4 (non-obstructive HCM) CK-3773274 (5 - 15 mg) Subjects will receive doses of 5 - 15 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 10 weeks CK-3773274 - Cohort 2 (Obstructive HCM) CK-3773274 (10 - 30 mg) Subjects will receive doses 10 - 30 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 10 weeks Placebo - Cohort 1 (Obstructive HCM) Placebo for CK-3773274 Subjects will receive placebo for up to 10 weeks Placebo - Cohort 2 (Obstructive HCM) Placebo for CK-3773274 Subjects will receive placebo for up to 10 weeks CK-3773274 & disopyramide - Cohort 3 (Obstructive HCM) CK-3773274 (5 - 15 mg) Subjects will receive doses 5 - 15 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide
- Primary Outcome Measures
Name Time Method Incidence of adverse events observed during dosing of CK--3773274 in patients with HCM 14 weeks Patient incidence of reported adverse events (AEs)
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM 14 weeks Patient incidence of reported serious adverse events (SAEs)
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM 14 weeks Patient incidence of left ventricular ejection fraction (LVEF) \< 50%
Concentration-response relationship of CK-3773274 on the resting left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment in patients with oHCM (Cohorts 1, 2, 3 only) 10 weeks Slope of the relationship of the plasma concentration of CK-3773274 to the change from baseline in the resting LVOT-G
Concentration-response relationship of CK-3773274 on the post-Valsalva left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment in patients with oHCM (Cohorts 1, 2, 3 only) 10 weeks Slope of the relationship of the plasma concentration of CK-3773274 to the change from baseline in the post-Valsalva LVOT-G
Dose response relationship on LVOT-G of CK-3773274 in patients with oHCM at rest (Cohorts 1, 2, 3 only) 10 weeks Change from baseline in resting LVOT-G over time as a function of dose
Dose response relationship on LVOT-G of CK-3773274 in patients with oHCM post-Valsalva (Cohorts 1, 2, 3 only) 10 weeks Change from baseline in post-Valsalva LVOT-G over time as a function of dose
Concentration-response relationship of CK-3773274 on left ventricular ejection fraction (LVEF) over 10 weeks of treatment in patients with HCM Day 1 to End of Study (EOS) (Week 14) Change from baseline in the resting LVEF
Trial Locations
- Locations (22)
New York University Langone Health Medical Center
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Erasmus University Medical Center (Erasmus MC)
🇳🇱Rotterdam, Netherlands
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
🇪🇸Madrid, Spain
Cedar-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Michigan Medicine - University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Duke Cardiology at Southpoint
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
🇺🇸Philadelphia, Pennsylvania, United States
UMPC Heart and Vascular Institute
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States