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

Bristol-Myers Squibb21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

DanicamtivDRUG

Specified dose on specified days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Anaheim Clinical Trials

Anaheim, California, United States

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

Time of maximum observed plasma concentration (Tmax)

Time frame: Up to day 16

Terminal elimination half-life (T-HALF)

Time frame: Up to day 16

Apparent total body clearance (CLT/F)

Time frame: Up to day 16

Apparent volume of distribution (Vz/F)

Time frame: Up to day 16

Number of participants with Adverse Events (AEs)

Time frame: Up to day 43

Number of participants with Serious Adverse Events (SAEs)

Time frame: Up to day 43

Number of participants with vital sign abnormalities

Time frame: Up to day 16

Number of participants with Electrocardiogram (ECG) abnormalities

Time frame: Up to day 16

Data from ClinicalTrials.gov

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