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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06027437
• Other study ID #: CV028-1012
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2023
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Danicamtiv
Specified dose on specified days.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to day 16
Primary	Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))		Up to day 16
Primary	Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))		Up to day 16
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to day 16
Secondary	Terminal elimination half-life (T-HALF)		Up to day 16
Secondary	Apparent total body clearance (CLT/F)		Up to day 16
Secondary	Apparent volume of distribution (Vz/F)		Up to day 16
Secondary	Number of participants with Adverse Events (AEs)		Up to day 43
Secondary	Number of participants with Serious Adverse Events (SAEs)		Up to day 43
Secondary	Number of participants with vital sign abnormalities		Up to day 16
Secondary	Number of participants with Electrocardiogram (ECG) abnormalities		Up to day 16
Secondary	Number of participants with Physical Examination (PE) abnormalities		Up to day 16
Secondary	Number of participants with clinical laboratory abnormalities		Up to day 16

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting