A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects

Official Title
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An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects

Conditions
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Immunoscience

Intervention / Treatment
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* Drug: Prenisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Specified dose on specified days | Drug: Prenisolone<br>* Specified dose on specified days<br>|
| Placebo Comparator: Arm B<br>Specified dose on specified days | Drug: Placebo<br>* Specified dose on dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 1 beta | As measured by flow cytometry | Up to 32 days | 
| Tumor necrosis factor-alpha | As measured by flow cytometry | Up to 32 days | 
| Receptor activator of nuclear factor-kB (RANK) | As measured by flow cytometry | Up to 32 days | 
| Receptor activator of nuclear factor-kB ligand (RANKL) | As measured by flow cytometry | Up to 32 days | 
| Osteoprotegrin (OPG) | As measured by flow cytometry | Up to 32 days | 
| Lipopolysaccharide Induced Cytokine Production | As measured by blood concentration | Up to 32 days | 
| Cell Populations | As measured by flow cytometry | Up to 32 days | 
| Oral glucose tolerance test | Assessed by central labortatory | Up to 32 days | 
| Cortisol | As measured by the level of the hormone cortisol in the blood | Up to 32 days | 
| Adrenocorticotropic hormone | As measured by the level of the hormone in the blood | Up to 32 days | 
| Osteocalcin | As measured by blood concentration | Up to 32 days | 
| N-terminal Pro-Collagen Peptide (PINP) | As measured by blood concentration | Up to 32 days | 
| Propetide type I C-term Pro-collagen Peptide (CICP) | As measured by blood concentration | Up to 32 days | 
| Bone-specific alkaline phosphatase | As measured by blood concentration | Up to 32 days | 
| Urinary deoxypyridinoline | As measured by urine concentration | Up to 32 days | 
| C Telopeptide of Collagen Type II (CTX-II) | As measured by urine concentration | Up to 32 days | 
| Calcium | As measured by urine concentration | Up to 32 days | 
| Creatinine | As measured by urine concentration | Up to 32 days |