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Danicamtiv

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06027437A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult ParticipantsPHASE1 COMPLETED 21 — — Sep 5, 2023Nov 10, 2023Nov 29, 20231 United States
NCT05806359A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian ParticipantsPHASE1 COMPLETED 33 — — Mar 31, 2023Aug 14, 2023May 23, 20241 United States
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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
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
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 -
Japanese Cohort - Dose 1EXPERIMENTAL -
Japanese Cohort - Dose 2EXPERIMENTAL -
Japanese Cohort - Dose 3EXPERIMENTAL -
Caucasian Cohort - Dose 3EXPERIMENTAL -
Interventions
NameTypeDescription
DanicamtivDRUGSpecified dose on specified days.
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 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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