Immunoscience
Conditions
Brief summary
The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects
Interventions
DRUGPrenisolone
Specified dose on specified days
DRUGPlacebo
Specified dose on dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 1 beta | Up to 32 days | As measured by flow cytometry |
| Tumor necrosis factor-alpha | Up to 32 days | As measured by flow cytometry |
| Receptor activator of nuclear factor-kB (RANK) | Up to 32 days | As measured by flow cytometry |
| Receptor activator of nuclear factor-kB ligand (RANKL) | Up to 32 days | As measured by flow cytometry |
| Osteoprotegrin (OPG) | Up to 32 days | As measured by flow cytometry |
| Lipopolysaccharide Induced Cytokine Production | Up to 32 days | As measured by blood concentration |
| Cell Populations | Up to 32 days | As measured by flow cytometry |
| Oral glucose tolerance test | Up to 32 days | Assessed by central labortatory |
| Cortisol | Up to 32 days | As measured by the level of the hormone cortisol in the blood |
| Adrenocorticotropic hormone | Up to 32 days | As measured by the level of the hormone in the blood |
| Osteocalcin | Up to 32 days | As measured by blood concentration |
| N-terminal Pro-Collagen Peptide (PINP) | Up to 32 days | As measured by blood concentration |
| Propetide type I C-term Pro-collagen Peptide (CICP) | Up to 32 days | As measured by blood concentration |
| Bone-specific alkaline phosphatase | Up to 32 days | As measured by blood concentration |
| Urinary deoxypyridinoline | Up to 32 days | As measured by urine concentration |
| C Telopeptide of Collagen Type II (CTX-II) | Up to 32 days | As measured by urine concentration |
| Calcium | Up to 32 days | As measured by urine concentration |
| Creatinine | Up to 32 days | As measured by urine concentration |
Countries
United States
Outcome results
None listed