A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
NCT ID: NCT06411730
Last Updated: 2024-11-12
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
56 participants
INTERVENTIONAL
2024-05-31
2024-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1A
BMS-986368
Specified dose on specified days
Cohort 1B
BMS-986368
Specified dose on specified days
Cohort 1C
BMS-986368
Specified dose on specified days
Cohort 2A
BMS-986368
Specified dose on specified days
Cohort 2B
BMS-986368
Specified dose on specified days
Cohort 2C
BMS-986368
Specified dose on specified days
Cohort 2D
BMS-986368
Specified dose on specified days
Cohort 3A
BMS-986368
Specified dose on specified days
Cohort 3B
BMS-986368
Specified dose on specified days
Interventions
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BMS-986368
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).
* Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive.
* Participants must have normal renal function at screening.
Exclusion Criteria
* Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.
* Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.
* Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.
* Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).
18 Years
80 Years
ALL
Yes
Sponsors
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Celgene
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 - 0001
Anaheim, California, 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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IM045-1009
Identifier Type: -
Identifier Source: org_study_id
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