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Completed

NCT Number: NCT06027437

A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danicamtiv

Drug

Specified dose on specified days.

Other names: BMS-986434, MYK-491

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to day 16

  2. Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to day 16

  3. 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

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to day 16

  2. Terminal elimination half-life (T-HALF)

    Time frame: Up to day 16

  3. Apparent total body clearance (CLT/F)

    Time frame: Up to day 16

  4. Apparent volume of distribution (Vz/F)

    Time frame: Up to day 16

  5. Number of participants with Adverse Events (AEs)

    Time frame: Up to day 43

  6. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to day 43

  7. Number of participants with vital sign abnormalities

    Time frame: Up to day 16

  8. Number of participants with Electrocardiogram (ECG) abnormalities

    Time frame: Up to day 16

  9. Number of participants with Physical Examination (PE) abnormalities

    Time frame: Up to day 16

  10. Number of participants with clinical laboratory abnormalities

    Time frame: Up to day 16

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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