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OpenTrials
Completed

NCT Number: NCT05806359

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

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Key information

Conditions

Age range

18 year–55 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 between 18 and 30 kilograms/meter squared inclusive, at the screening visit.
  • Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).
  • Caucasian participants must be of European or Latin American Caucasian descent.
  • A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.
  • Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.

Exclusion criteria

  • Any acute or chronic medical illness.
  • Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.
  • History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

Danicamtiv

Drug

Specified dose on specified days

Other names: BMS-986434, MYK-491

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Day 1 up to Day 28

  2. Number of Participants with Vital Sign Abnormalities

    Time frame: Day 1 up to Day 7

  3. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Day 1 up to Day 7

  4. Number of Participants with Physical Examination Abnormalities

    Time frame: Day 1 up to Day 7

  5. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Day 1 up to Day 7

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

  2. Time of Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

  3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]

    Time frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
May 23, 2024

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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