A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
NCT ID: NCT04882150
Last Updated: 2023-01-12
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
102 participants
INTERVENTIONAL
2021-05-27
2022-06-10
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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Part A: SAD
SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
BMS-986196
Specified dose on specified days
Placebo
Specified dose on specified days
Part B: MAD
MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
BMS-986196
Specified dose on specified days
Placebo
Specified dose on specified days
Part C: FE/Formul.
FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food.
BMS-986196
Specified dose on specified days
Interventions
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BMS-986196
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg
Exclusion Criteria
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Presence of any factors that would predispose the participant to develop infection
* A history of bacterial or fungal meningitis within 1 year prior to screening
* A history of intracranial or intraspinal bleeding
* Known intracranial space-occupying mass, including meningioma
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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Local Institution - 0002
Salt Lake City, Utah, 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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IM038-008
Identifier Type: -
Identifier Source: org_study_id
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