Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
NCT ID: NCT02705989
Last Updated: 2019-01-30
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
439 participants
INTERVENTIONAL
2016-08-18
2017-08-16
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 (SAD)
Single ascending dose of BMS-986195 or Placebo matching BMS-986195
BMS-986195
Specified dose on specified day
Placebo
Specified dose on specified day
Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195
BMS-986195
Specified dose on specified day
Placebo
Specified dose on specified day
Japanese-Multiple Ascending Dose(MAD)
Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
BMS-986195
Specified dose on specified day
Placebo
Specified dose on specified day
Relative Bioavailability with Food Effects (Open Label)
BMS-986195
Specified dose on specified day
Interventions
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BMS-986195
Specified dose on specified day
Placebo
Specified dose on specified day
Eligibility Criteria
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Inclusion Criteria
* Healthy male and female, first generation Japanese with confirmed paternal and maternal Japanese ancestry, 18-55 years old, whose residency outside of Japan does not exceed 10 years with a BMI of 18-30 kilograms/meter\^2 inclusive.
* Women must not be pregnant or breastfeeding
* Women of Childbearing Potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required.
Exclusion Criteria
* Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosis, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (example: history of splenectomy)
* Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of preexisting skin conditions that increase risks for injection site complications e.g. Behcet's Disease, Psoriasis, pustular dermatoses
* Any history or risk for tuberculosis (TB)
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
Melbourne, Victoria, Australia
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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IM014-001
Identifier Type: -
Identifier Source: org_study_id
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