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Danicamtiv

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Danicamtiv · 4 trials · 3 indications

Phase 1 4
NCT06027437A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult ParticipantsHealthy Volunteers
COMPLETED21 Analytics
NCT05952089A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart FailureHeart Failure With Reduced Ejection Fraction
COMPLETED13 Analytics
NCT05806359A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian ParticipantsHealthy Volunteers
COMPLETED33 Analytics
NCT05162222A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy ParticipantsHealthy Participants
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
Healthy Volunteers
NCT0602743721
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PHASE1COMPLETED
A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure
Heart Failure With Reduced Ejection Fraction
NCT0595208913
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PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
Healthy Volunteers
NCT0580635933
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PHASE1COMPLETED
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants
Healthy Participants
NCT0516222230
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax)
Up to day 16
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
Up to day 16
Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to day 16
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF])
Up to Day 12
Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to Day 12
Number of Participants with Adverse Events (AEs)
Day 1 up to Day 28
Number of Participants with Vital Sign Abnormalities
Day 1 up to Day 7
Number of Participants with Electrocardiogram (ECG) Abnormalities
Day 1 up to Day 7
Number of Participants with Physical Examination Abnormalities
Day 1 up to Day 7
Number of Participants with Clinical Laboratory Abnormalities
Day 1 up to Day 7
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Up to 17 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Up to 17 days

Secondary Endpoints

Time of maximum observed plasma concentration (Tmax)
Up to day 16
Terminal elimination half-life (T-HALF)
Up to day 16
Apparent total body clearance (CLT/F)
Up to day 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment CEXPERIMENTAL -
Danicamtiv + MidazolamEXPERIMENTAL -
Japanese Cohort - Dose 1EXPERIMENTAL -
Japanese Cohort - Dose 2EXPERIMENTAL -
Japanese Cohort - Dose 3EXPERIMENTAL -
Caucasian Cohort - Dose 3EXPERIMENTAL -
Danicamtiv, followed by itraconazole + danicamtivEXPERIMENTAL -
Danicamtiv, followed by diltiazem + danicamtivEXPERIMENTAL -

Interventions

NameTypeDescription
DanicamtivDRUGSpecified dose on specified days.
MidazolamDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
DiltiazemDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive * Participants with resting heart rate ≥ 55 bpm * Seasonal allergies that do not require medication at the time of the study are acceptable Exclusion Criteria: * Any acute or chronic medical illness * Head injury, i...

Countries:United States
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Frequently asked questions about Danicamtiv

What is Danicamtiv used for?

Danicamtiv is an investigational small molecule being studied in healthy participants and in patients with heart failure with reduced ejection fraction. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does Danicamtiv target?

Danicamtiv is a small molecule being developed by Bristol-Myers Squibb Company (BMY) for heart failure with reduced ejection fraction. Its specific molecular target has not been disclosed in the available information.

Who makes Danicamtiv?

Danicamtiv is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy participants and in patients with heart failure with reduced ejection fraction.

What phase is Danicamtiv in?

Danicamtiv is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Bristol-Myers Squibb Company (BMY) is the developer, and all completed trials are Phase 1 studies.

What clinical trials is Danicamtiv in?

Danicamtiv has completed four Phase 1 trials: NCT05162222, NCT05806359, NCT05952089, and NCT06027437. These studies evaluated drug interactions, safety in Japanese and Caucasian participants, effects on midazolam levels in heart failure patients, and bioavailability with food.

Is Danicamtiv the same as MYK-491?

Danicamtiv is also known as MYK-491. It is an investigational small molecule being developed by Bristol-Myers Squibb Company (BMY) for heart failure with reduced ejection fraction, and it is currently in Phase 1 clinical trials.