A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
NCT ID: NCT03198013
Last Updated: 2020-06-09
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
120 participants
INTERVENTIONAL
2008-11-11
2009-05-18
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
DOUBLE
Study Groups
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Module A
Single Ascending Dose
Prednisolone
Specified dose on specified days
BMS-791826
Specified dose on specified days
Placebo
Specified dose on specified days
Module B
Multiple Ascending Dose
Prednisolone
Specified dose on specified days
BMS-791826
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Prednisolone
Specified dose on specified days
BMS-791826
Specified dose on specified days
Placebo
Specified 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
* History of Gilbert's disease
18 Years
55 Years
MALE
No
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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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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IM125-001
Identifier Type: -
Identifier Source: org_study_id
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