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

November 27, 2023 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment B
Drug: Danicamtiv
Specified dose on specified days.
Other Names:
  • MYK-491
  • BMS-986434
Experimental: Treatment C
Drug: Danicamtiv
Specified dose on specified days.
Other Names:
  • MYK-491
  • BMS-986434
Experimental: Treatment A
Drug: Danicamtiv
Specified dose on specified days.
Other Names:
  • MYK-491
  • BMS-986434

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to day 16
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
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
Up to day 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to day 16
Up to day 16
Terminal elimination half-life (T-HALF)
Time Frame: Up to day 16
Up to day 16
Apparent total body clearance (CLT/F)
Time Frame: Up to day 16
Up to day 16
Apparent volume of distribution (Vz/F)
Time Frame: Up to day 16
Up to day 16
Number of participants with Adverse Events (AEs)
Time Frame: Up to day 43
Up to day 43
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to day 43
Up to day 43
Number of participants with vital sign abnormalities
Time Frame: Up to day 16
Up to day 16
Number of participants with Electrocardiogram (ECG) abnormalities
Time Frame: Up to day 16
Up to day 16
Number of participants with Physical Examination (PE) abnormalities
Time Frame: Up to day 16
Up to day 16
Number of participants with clinical laboratory abnormalities
Time Frame: Up to day 16
Up to day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CV028-1012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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