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 Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Danicamtiv

Study type: Interventional

Funder types: Industry

Identifiers

NCT06027437

CV028-1012

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Treatment A

Experimental group

Treatment:

Drug: Danicamtiv

Treatment B

Experimental group

Treatment:

Drug: Danicamtiv

Treatment C

Experimental group

Treatment:

Drug: Danicamtiv