Immunoscience
Conditions
Brief summary
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
Interventions
DRUGPrednisolone
Specified dose on specified days
DRUGBMS-791826
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Inclusion criteria
* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive * Signed informed consent
Exclusion criteria
* Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP) * Any significant acute or chronic medical illness * History of Gilbert's disease Other protocol inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 34 days | safety and tolerability |
| Incidence of serious adverse events (SAEs) | Up to 34 days | safety and tolerability |
Countries
Australia
Outcome results
None listed