A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
NCT ID: NCT03196557
Last Updated: 2019-12-06
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
2008-03-31
2008-05-05
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
BASIC_SCIENCE
NONE
Study Groups
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Arm A
Specified dose on specified days
Prenisolone
Specified dose on specified days
Arm B
Specified dose on specified days
Placebo
Specified dose on dose on specified days
Interventions
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Prenisolone
Specified dose on specified days
Placebo
Specified dose on dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
* Signed informed consent
Exclusion Criteria
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease including peptic ulcer
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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Ppd Development
Austin, Texas, United States
Local Institution
Austin, Texas, United States
Countries
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References
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Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.
Other Identifiers
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IM124-001
Identifier Type: -
Identifier Source: org_study_id