A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
NCT ID: NCT05806359
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2023-03-31
2023-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Japanese Cohort - Dose 1
Danicamtiv
Specified dose on specified days
Placebo
Specified dose on specified days
Japanese Cohort - Dose 2
Danicamtiv
Specified dose on specified days
Placebo
Specified dose on specified days
Japanese Cohort - Dose 3
Danicamtiv
Specified dose on specified days
Placebo
Specified dose on specified days
Caucasian Cohort - Dose 3
Danicamtiv
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Danicamtiv
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Anaheim Clinical Trials
Anaheim, California, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CV028-1001
Identifier Type: -
Identifier Source: org_study_id
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