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

Bristol-Myers Squibb1 site in 1 country21 target enrollmentSeptember 5, 2023

ConditionsHealthy Volunteers

InterventionsDanicamtiv

DrugsDanicamtiv

Overview

Phase: Phase 1
Intervention: Danicamtiv
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb
Enrollment: 21
Locations: 1
Primary Endpoint: Maximum observed plasma concentration (Cmax)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 5, 2023

End Date

November 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Treatment A

Intervention: Danicamtiv

Treatment B

Intervention: Danicamtiv

Treatment C

Intervention: Danicamtiv

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax)

Time Frame: Up to day 16

Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))

Time Frame: 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))

Time Frame: Up to day 16

Secondary Outcomes

Number of participants with Electrocardiogram (ECG) abnormalities(Up to day 16)
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)
Apparent volume of distribution (Vz/F)(Up to day 16)
Number of participants with vital sign abnormalities(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)
Number of participants with Physical Examination (PE) abnormalities(Up to day 16)
Number of participants with clinical laboratory abnormalities(Up to day 16)