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
24 participants
INTERVENTIONAL
2017-08-15
2017-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMS-986195
A single oral solution dose of BMS-986195
BMS-986195
specified dose on specified days
Interventions
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BMS-986195
specified dose on specified days
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), and total body weight \>50 kg
* All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
* All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
* Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator
Exclusion Criteria
* Known previous exposure to BMS-986195
* Employee of PRA or the Sponsor
* History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
* Using tobacco products within 60 days prior to drug administration
* Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
18 Years
55 Years
MALE
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
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2017-002706-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM014-016
Identifier Type: -
Identifier Source: org_study_id
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