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CK-3773274- Granules in

Phase 1

Symptomatic Obstructive Hypertrophic Cardiomyopathy | Small molecule | Cardiovascular |Cytokinetics, Incorporated|Last Updated: Jan 24, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

CK-3773274- Granules in · 1 trial · 2 indications

Phase 1 1
NCT03767855A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult SubjectsSymptomatic Obstructive Hypertrophic Cardiomyopathy
COMPLETED114 Analytics
PHASE1COMPLETED
A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
Symptomatic Obstructive Hypertrophic CardiomyopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse events and Safety Signals observed during single and multiple ascending doses of CK-3773274 administered orally to healthy adult subjects.
SAD Cohorts: Day -1 - Day 10; CYP2D6 Cohort: Day -1 - Day - 24; MAD Cohorts: Day -1 - Day 27; Food Effect Cohort: Day -1 - Day 24; relative Bioavailability Cohort: Day -1 - Day 29

Subject incidence of AEs, SAEs, and reduced LVEF

Secondary Endpoints

Cmax of CK-3773274 after single and multiple ascending doses
SAD Cohorts: Day 1; CYP2D6 Cohort: Day 1; MAD Cohorts: Day 14 or Day 17; Food Effect Cohort: Day 15; Relative Bioavailability Cohort: Day 15
Change in absolute reduction in ejection fraction relative to baseline with doses of CK-3773274
Time Frame for SAD Cohorts: Day -1 - Day 10; Time Frame for CYP2D6 Cohort: Day -1 - Day 24; Time Frame for MAD Cohorts: Day -1 - Day 27
Assess the effect of CYP2D6 genetic variants on the PK of CK-3773274
Day -1 - Day 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
CK-3773274 for SAD CohortsEXPERIMENTALSubjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-3773274
Placebo for SAD CohortsPLACEBO_COMPARATORSubjects will be assigned to one of 8 planned dose cohorts and receive single doses of placebo
CK-3773274 for MAD CohortsEXPERIMENTALSubjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of CK-3773274
Placebo for MAD CohortsPLACEBO_COMPARATORSubjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of placebo
CK-3773274 for CYP2D6 CohortEXPERIMENTALSubjects with CYP2D6 poor metabolizer phenotype will be assigned to receive a single dose of CK-3773274
Placebo for CYP2D6 CohortPLACEBO_COMPARATORSubjects with CYP2D6 poor metabolizer phenotype will be assigned to receive a single dose of placebo
Food EffectEXPERIMENTALSubjects will be administered CK-3773274 with and without food in a randomized cross-over fashion
Relative BioavailabilityEXPERIMENTALSubjects will be administered CK-3773274 as granules in a capsule and as a tablet in a randomized cross-over fashion.

Interventions

NameTypeDescription
CK-3773274 - Granules in CapsuleDRUGCK-3773274 formulated as granules in capsule
Placebo - Granules in CapsuleDRUGPlacebo formulated as granules in capsule
CK-3773274 - TabletsDRUGCK-3773274 formulated as tablets
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males and females (of non-childbearing potential) between 18 and 55 years of age, inclusive 2. Body weight \> 55.0 kg and body mass index within 18.0 to 32.0 kg/m2, inclusive 3. Normal cardiac structure and function, or if abnormalities are present, they are deemed not clinic...

Countries:United States
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Frequently asked questions about CK-3773274- Granules in

What is CK-3773274 used for?

CK-3773274 is an investigational small molecule being developed for the treatment of symptomatic obstructive hypertrophic cardiomyopathy, a cardiovascular condition. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes CK-3773274?

CK-3773274 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CYTK. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.

What phase is CK-3773274 in?

CK-3773274 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for safety and dosing in humans.

What clinical trials is CK-3773274 in?

CK-3773274 has one completed Phase 1 trial, NCT03767855, titled "A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects." This randomized, double-blind, placebo-controlled study enrolled 114 participants in the United States, including healthy volunteers.

Is CK-3773274 the same as any other drug?

No alternative names for CK-3773274 have been reported. The drug is identified solely by its code name CK-3773274 in clinical trial registries and by its developer, Cytokinetics, Incorporated.