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The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Specified dose on specified days |
|
| Arm B | Placebo Comparator | Specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenisolone | Drug | Specified dose on specified days |
| |
| Placebo |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development | Austin | Texas | 78744 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29534336 | Derived | 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. |
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| Drug |
Specified dose on dose on specified days |
|
| 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 |
| Austin |
| Texas |
| 78759 |
| United States |