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The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module A | Experimental | Single Ascending Dose |
|
| Module B | Experimental | Multiple Ascending Dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | safety and tolerability | Up to 34 days |
| Incidence of serious adverse events (SAEs) | safety and tolerability | Up to 34 days |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| 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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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| C568960 | 5-2-(4-((ethylmethylamino)carbonyl)-3-fluorophenyl)-alpha,alpha-dimethyl-N-1,3,4-thiadiazol-2-yl-5H-(1)benzopyrano(2,3-b)pyridin-5-acetamide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| BMS-791826 |
| Drug |
Specified dose on specified days |
|
| Placebo | Drug | Specified dose on specified days |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |