Clinical trial NCT06027437: A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986434
MYK-491
Healthy
Biological Availability
Food Effect
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-09-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to day 16
measure: Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to day 16
measure: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to day 16
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to day 16
measure: Terminal elimination half-life (T-HALF)
timeFrame: Up to day 16
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to day 16
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to day 16
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to day 43
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to day 43
measure: Number of participants with vital sign abnormalities
timeFrame: Up to day 16
measure: Number of participants with Electrocardiogram (ECG) abnormalities
timeFrame: Up to day 16
measure: Number of participants with Physical Examination (PE) abnormalities
timeFrame: Up to day 16
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to day 16
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: