A Study of Experimental Medication BMS-986278 Given to Healthy Participants
NCT ID: NCT03429933
Last Updated: 2019-10-01
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
112 participants
INTERVENTIONAL
2018-02-07
2019-03-02
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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Single Ascending Dose
BMS-986278 or placebo
BMS-986278
Specified dose on specified days
Placebo
Specified dose on specified days
Multiple Ascending Dose
BMS-986278 or placebo
BMS-986278
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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BMS-986278
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
* Body weight between 55 and 105 kg, inclusive, at screening
* Female participants must have documented proof that they are not of childbearing potential
* Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
Exclusion Criteria
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any major surgery within 6 weeks of study drug administration
21 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
Groningen, , Netherlands
Local Institution
London, , United Kingdom
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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2017-004136-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM027-009
Identifier Type: -
Identifier Source: org_study_id
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