A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
NCT ID: NCT04965389
Last Updated: 2023-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2021-07-16
2021-10-01
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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Treatment Sequence 1
BMS-986177 Oral Solution
Specified dose on specified days
[14C]BMS-986177 Solution for Infusion
Specified dose on specified days
BMS-986177 Spray-dried Dispersion Capsules
Specified dose on specified days
Treatment Sequence 2
BMS-986177 Oral Solution
Specified dose on specified days
[14C]BMS-986177 Solution for Infusion
Specified dose on specified days
BMS-986177 Spray-dried Dispersion Capsules
Specified dose on specified days
Treatment Sequence 3
BMS-986177 Oral Solution
Specified dose on specified days
[14C]BMS-986177 Solution for Infusion
Specified dose on specified days
BMS-986177 Spray-dried Dispersion Capsules
Specified dose on specified days
Treatment Sequence 4
BMS-986177 Oral Solution
Specified dose on specified days
[14C]BMS-986177 Solution for Infusion
Specified dose on specified days
BMS-986177 Spray-dried Dispersion Capsules
Specified dose on specified days
Interventions
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BMS-986177 Oral Solution
Specified dose on specified days
[14C]BMS-986177 Solution for Infusion
Specified dose on specified days
BMS-986177 Spray-dried Dispersion Capsules
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height \[m\])²
Exclusion Criteria
* History or evidence of abnormal bleeding or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such as epistaxis, or family history of coagulopathies
* Any acute or chronic medical illness considered clinically significant by the investigator
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, neurological or psychiatric disorder, as judged by the investigator
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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Local Institution
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
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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2021-000892-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV010-062
Identifier Type: -
Identifier Source: org_study_id
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