A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants

A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06027437

Enrollment

Registered

2023-09-07

Start date

2023-09-05

Completion date

2023-11-10

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

BMS-986434, MYK-491, Healthy, Biological Availability, Food Effect

Brief summary

The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.

Interventions

DRUGDanicamtiv

Specified dose on specified days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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, intracranial tumor, or aneurysm within 2 years prior to screening * History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Apparent volume of distribution (Vz/F)	Up to day 16
Number of participants with Adverse Events (AEs)	Up to day 43
Number of participants with Serious Adverse Events (SAEs)	Up to day 43
Time of maximum observed plasma concentration (Tmax)	Up to day 16
Number of participants with Electrocardiogram (ECG) abnormalities	Up to day 16
Number of participants with Physical Examination (PE) abnormalities	Up to day 16
Number of participants with clinical laboratory abnormalities	Up to day 16
Number of participants with vital sign abnormalities	Up to day 16
Terminal elimination half-life (T-HALF)	Up to day 16
Apparent total body clearance (CLT/F)	Up to day 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026