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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 9 November 2020
Main ID:  EUCTR2019-002785-12-GB
Date of registration: 31/12/2019
Prospective Registration: Yes
Primary sponsor: Cytokinetics, Inc.
Public title: Pharmacokinetic and Pharmacodynamic study to evaluate the effect of CK-3773274 in patients with obstructive hypertrophic cardiomyopathy (oHCM)
Scientific title: A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
Date of first enrolment: 08/05/2020
Target sample size: 60
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002785-12
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Italy Netherlands Spain United Kingdom United States
Contacts
Name: Medical Affairs   
Address:  280 East Grand Avenue 94080 South San Francisco CA United States
Telephone: 16506242929
Email: medicalaffairs@cytokinetics.com
Affiliation:  Cytokinetics Inc
Name: Medical Affairs   
Address:  280 East Grand Avenue 94080 South San Francisco CA United States
Telephone: 16506242929
Email: medicalaffairs@cytokinetics.com
Affiliation:  Cytokinetics Inc
Key inclusion & exclusion 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 <50 mmHg with post-Valsalva LVOT G =50 mmHg
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.

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:
- 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 <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.
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Intervention(s)

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-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

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-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

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-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

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-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To determine the safety and tolerability of CK­3773274 in patients with symptomatic oHCM
Primary end point(s): • Patient incidence of reported AEs
• Patient incidence of reported SAEs
• Patient incidence of LVEF < 50%
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.
Timepoint(s) of evaluation of this end point: Week 14
Secondary Outcome(s)
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
Secondary ID(s)
2019-002785-12-ES
CY6021
Source(s) of Monetary Support
Cytokinetics, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 08/05/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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