CK-3773274 (10 - 30 mg) for Obstructive Hypertrophic Cardiomyopathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Obstructive Hypertrophic Cardiomyopathy+4 More
CK-3773274 (10 - 30 mg) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effect of different doses of a drug on patients with a heart condition.

Eligible Conditions
  • Obstructive Hypertrophic Cardiomyopathy
  • Hypertrophic Cardiomyopathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Day 1 to End of Study (EOS) (Week 14)

10 weeks
Concentration-response relationship of CK-3773274 on the post-Valsalva left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment
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)
Concentration-response relationship of CK-3773274 on the resting left ventricular outflow tract gradient (LVOT-G) on echocardiogram over 10 weeks of treatment
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)
Dose response relationship of CK-3773274 in patients with oHCM at rest
Dose response relationship of CK-3773274 in patients with oHCM post-Valsalva
Dose response relationship on LVOT-G of CK-3773274 in patients with oHCM at rest (Cohorts 1, 2, 3 only)
Dose response relationship on LVOT-G of CK-3773274 in patients with oHCM post-Valsalva (Cohorts 1, 2, 3 only)
14 weeks
Incidence of adverse events observed during dosing of CK--3773274 in patients with HCM
Incidence of adverse events observed during dosing of CK-3773274 in patients with oHCM
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM
Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of during dosing of CK-3773274 in patients with oHCM
Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM
Incidence of serious adverse events observed during dosing of CK-3773274 in patients with oHCM
Week 14
Concentration-response relationship of CK-3773274 on left ventricular ejection fraction (LVEF) over 10 weeks of treatment in patients with HCM
Plasma concentrations of CK-3773274 in patients with oHCM

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

11 Treatment Groups

CK-3773274 & disopyramide - Cohort 3
1 of 11
CK-3773274 - Cohort 1
1 of 11
CK-3773274 - Cohort 2
1 of 11
CK-3773274 - Cohort 2 (Obstructive HCM)
1 of 11
CK-3773274 - Cohort 1 (Obstructive HCM)
1 of 11
CK-3773274 & disopyramide - Cohort 3 (Obstructive HCM)
1 of 11
CK-3773274 - Cohort 4 (non-obstructive HCM)
1 of 11
Placebo - Cohort 2
1 of 11
Placebo - Cohort 1
1 of 11
Placebo - Cohort 2 (Obstructive HCM)
1 of 11
Placebo - Cohort 1 (Obstructive HCM)
1 of 11

Experimental Treatment

Non-Treatment Group

95 Total Participants · 11 Treatment Groups

Primary Treatment: CK-3773274 (10 - 30 mg) · Has Placebo Group · Phase 2

CK-3773274 & disopyramide - Cohort 3
Drug
Experimental Group · 1 Intervention: CK-3773274 (5 - 15 mg) · Intervention Types: Drug
CK-3773274 - Cohort 1
Drug
Experimental Group · 1 Intervention: CK-3773274 (5 - 15 mg) · Intervention Types: Drug
CK-3773274 - Cohort 2
Drug
Experimental Group · 1 Intervention: CK-3773274 (10 - 30 mg) · Intervention Types: Drug
CK-3773274 - Cohort 2 (Obstructive HCM)
Drug
Experimental Group · 1 Intervention: CK-3773274 (10 - 30 mg) · Intervention Types: Drug
CK-3773274 - Cohort 1 (Obstructive HCM)
Drug
Experimental Group · 1 Intervention: CK-3773274 (5 - 15 mg) · Intervention Types: Drug
CK-3773274 & disopyramide - Cohort 3 (Obstructive HCM)
Drug
Experimental Group · 1 Intervention: CK-3773274 (5 - 15 mg) · Intervention Types: Drug
CK-3773274 - Cohort 4 (non-obstructive HCM)
Drug
Experimental Group · 1 Intervention: CK-3773274 (5 - 15 mg) · Intervention Types: Drug
Placebo - Cohort 2
Drug
PlaceboComparator Group · 1 Intervention: Placebo for CK-3773274 · Intervention Types: Drug
Placebo - Cohort 1
Drug
PlaceboComparator Group · 1 Intervention: Placebo for CK-3773274 · Intervention Types: Drug
Placebo - Cohort 2 (Obstructive HCM)
Drug
PlaceboComparator Group · 1 Intervention: Placebo for CK-3773274 · Intervention Types: Drug
Placebo - Cohort 1 (Obstructive HCM)
Drug
PlaceboComparator Group · 1 Intervention: Placebo for CK-3773274 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to end of study (eos) (week 14)

Who is running the clinical trial?

CytokineticsLead Sponsor
35 Previous Clinical Trials
14,453 Total Patients Enrolled
1 Trials studying Obstructive Hypertrophic Cardiomyopathy
28 Patients Enrolled for Obstructive Hypertrophic Cardiomyopathy
Cytokinetics, MDStudy DirectorCytokinetics
3 Previous Clinical Trials
1,131 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18 and 85 years.\n
You have left ventricular hypertrophy with non-dilated LV chamber in the absence of other cardiac disease.
You have a positive family history of HCM or a known disease-causing gene mutation.
For Cohort 4 has elevated NT-proBNP > 300 pg/mL at the time of screening.
You have NYHA Class II or III heart failure.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.