Clinical trial NCT03196557: A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
Official title: An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunoscience
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
* Signed informed consent

Exclusion Criteria:

* Women
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease including peptic ulcer

Other protocol inclusion/exclusion criteria may apply

Primary outcomes:
measure: Interleukin 1 beta
timeFrame: Up to 32 days
measure: Tumor necrosis factor-alpha
timeFrame: Up to 32 days
measure: Receptor activator of nuclear factor-kB (RANK)
timeFrame: Up to 32 days
measure: Receptor activator of nuclear factor-kB ligand (RANKL)
timeFrame: Up to 32 days
measure: Osteoprotegrin (OPG)
timeFrame: Up to 32 days
measure: Lipopolysaccharide Induced Cytokine Production
timeFrame: Up to 32 days
measure: Cell Populations
timeFrame: Up to 32 days
measure: Oral glucose tolerance test
timeFrame: Up to 32 days
measure: Cortisol
timeFrame: Up to 32 days
measure: Adrenocorticotropic hormone
timeFrame: Up to 32 days
measure: Osteocalcin
timeFrame: Up to 32 days
measure: N-terminal Pro-Collagen Peptide (PINP)
timeFrame: Up to 32 days
measure: Propetide type I C-term Pro-collagen Peptide (CICP)
timeFrame: Up to 32 days
measure: Bone-specific alkaline phosphatase
timeFrame: Up to 32 days
measure: Urinary deoxypyridinoline
timeFrame: Up to 32 days
measure: C Telopeptide of Collagen Type II (CTX-II)
timeFrame: Up to 32 days
measure: Calcium
timeFrame: Up to 32 days
measure: Creatinine
timeFrame: Up to 32 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development
state: Texas
city: Austin
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.