Dose-finding Study to Evaluate the Safety, Tolerability, PK, and PD of CK-3773274 in Adults With HCM
NCT ID: NCT04219826
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2020-01-10
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CK-3773274 - Cohort 1 (Obstructive HCM)
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 (5 - 15 mg)
CK-3773274 tablets administered orally
Placebo - Cohort 1 (Obstructive HCM)
Subjects will receive placebo for up to 10 weeks
Placebo for CK-3773274
Placebo administered orally
CK-3773274 - Cohort 2 (Obstructive HCM)
Subjects will receive doses 10 - 30 mg of CK-3773274 with dose levels guided by echocardiography assessments for up to 10 weeks
CK-3773274 (10 - 30 mg)
CK-3773274 tablets administered orally
Placebo - Cohort 2 (Obstructive HCM)
Subjects will receive placebo for up to 10 weeks
Placebo for CK-3773274
Placebo administered orally
CK-3773274 & disopyramide - Cohort 3 (Obstructive HCM)
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
CK-3773274 (5 - 15 mg)
CK-3773274 tablets administered orally
CK-3773274 - Cohort 4 (non-obstructive HCM)
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 (5 - 15 mg)
CK-3773274 tablets administered orally
Interventions
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CK-3773274 (5 - 15 mg)
CK-3773274 tablets administered orally
CK-3773274 (10 - 30 mg)
CK-3773274 tablets administered orally
Placebo for CK-3773274
Placebo administered orally
Eligibility Criteria
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Inclusion Criteria
* Body weight is ≥45 kg at screening.
* Diagnosed with HCM per the following criteria:
* Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
* Has minimal wall thickness ≥15 mm (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.
* For Cohorts 1, 2 and 3 has LVOT-G during screening as follows:
* Resting gradient ≥50 mmHg OR
* Resting gradient ≥30 mmHg and \<50 mmHg with post-Valsalva LVOT-G ≥50 mmHg
* For Cohort 4 has resting and post-Valsalva LVOT-G \< 30 mmHg at the time of screening
* For Cohort 4 has elevated NT-proBNP \> 300 pg/mL at the time of screening
* LVEF ≥60% at screening.
* New York Heart Association (NYHA) Class II or III at screening.
* Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for \>4 weeks prior to randomization and anticipate remaining on the same medication regimen during the study.
* For Cohort 3: Patients must be taking disopyramide. Patients should have been on stable disopyramide doses for \>4 weeks prior to screening and anticipate remaining on the same medication regimen during the study.
Exclusion Criteria
* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
* History of LV systolic dysfunction (LVEF \<45%) at any time during their clinical course.
* Documented history of current obstructive coronary artery disease (\>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 (Cohorts 1, 2, and 3 only). Patients having undergone septal reduction therapy \> 12 months prior to screening who remain symptomatic from nHCM, and who meet all other criteria for inclusion, may be enrolled in Cohort 4.
* For Cohorts 1, 2 and 4: Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening. (For Cohort 3, use of disopyramide is required).
* Has any ECG abnormality considered by the investigator to pose a risk to patient safety (eg, second degree atrioventricular block type II).
* 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 CK-3773274 or mavacamten.
18 Years
85 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Cytokinetics, MD
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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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
Washington University School of Medicine
St Louis, Missouri, United States
New York University Langone Health Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, 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
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Erasmus University Medical Center (Erasmus MC)
Rotterdam, , Netherlands
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, , Spain
Countries
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References
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Masri A, Sherrid MV, Abraham TP, Choudhury L, Garcia-Pavia P, Kramer CM, Barriales-Villa R, Owens AT, Rader F, Nagueh SF, Olivotto I, Saberi S, Tower-Rader A, Wong TC, Coats CJ, Watkins H, Fifer MA, Solomon SD, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Meng L, Sohn RL, Wohltman A, Maron MS; REDWOOD-HCM Investigators. Efficacy and Safety of Aficamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Results From the REDWOOD-HCM Trial, Cohort 4. J Card Fail. 2024 Nov;30(11):1439-1448. doi: 10.1016/j.cardfail.2024.02.020. Epub 2024 Mar 15.
Zampieri M, Argiro A, Marchi A, Berteotti M, Targetti M, Fornaro A, Tomberli A, Stefano P, Marchionni N, Olivotto I. Mavacamten, a Novel Therapeutic Strategy for Obstructive Hypertrophic Cardiomyopathy. Curr Cardiol Rep. 2021 Jun 3;23(7):79. doi: 10.1007/s11886-021-01508-0.
Other Identifiers
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2019-002785-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CY 6021
Identifier Type: -
Identifier Source: org_study_id
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