A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants
NCT ID: NCT05162222
Last Updated: 2022-08-10
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
30 participants
INTERVENTIONAL
2021-12-15
2022-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Danicamtiv, followed by itraconazole + danicamtiv
Danicamtiv
Specified dose on specified days
Itraconazole
Specified dose on specified days
Danicamtiv, followed by diltiazem + danicamtiv
Danicamtiv
Specified dose on specified days
Diltiazem
Specified dose on specified days
Interventions
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Danicamtiv
Specified dose on specified days
Itraconazole
Specified dose on specified days
Diltiazem
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Normal ECG at the Screening Visit
* Normal renal function at Screening
Exclusion Criteria
* History of heart disease or conduction disorders
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration)
18 Years
65 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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Covance Clinical Research Unit - Dallas
Dallas, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CV028-008
Identifier Type: -
Identifier Source: org_study_id
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