NCT06027437CompletedPhase 1
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 enrollmentStarted: September 5, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Treatment A
Experimental
Intervention: Danicamtiv (Drug)
Treatment B
Experimental
Intervention: Danicamtiv (Drug)
Treatment C
Experimental
Intervention: Danicamtiv (Drug)
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)
Investigators
Study Sites (1)
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