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

May 21, 2024 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Japanese Cohort - Dose 1
Drug: Placebo
Specified dose on specified days
Drug: Danicamtiv
Specified dose on specified days
Other Names:
  • MYK-491
  • BMS-986434
Experimental: Japanese Cohort - Dose 2
Drug: Placebo
Specified dose on specified days
Drug: Danicamtiv
Specified dose on specified days
Other Names:
  • MYK-491
  • BMS-986434
Experimental: Japanese Cohort - Dose 3
Drug: Placebo
Specified dose on specified days
Drug: Danicamtiv
Specified dose on specified days
Other Names:
  • MYK-491
  • BMS-986434
Experimental: Caucasian Cohort - Dose 3
Drug: Placebo
Specified dose on specified days
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
Number of Participants with Adverse Events (AEs)
Time Frame: Day 1 up to Day 28
Day 1 up to Day 28
Number of Participants with Vital Sign Abnormalities
Time Frame: Day 1 up to Day 7
Day 1 up to Day 7
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time Frame: Day 1 up to Day 7
Day 1 up to Day 7
Number of Participants with Physical Examination Abnormalities
Time Frame: Day 1 up to Day 7
Day 1 up to Day 7
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Day 1 up to Day 7
Day 1 up to Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Time of Maximum Observed Plasma Concentration (Tmax)
Time Frame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
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
Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

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)

March 31, 2023

Primary Completion (Actual)

August 14, 2023

Study Completion (Actual)

August 14, 2023

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CV028-1001

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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