A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
- Registration Number
- NCT03198013
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
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/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Module B Prednisolone Multiple Ascending Dose Module B BMS-791826 Multiple Ascending Dose Module B Placebo Multiple Ascending Dose Module A Prednisolone Single Ascending Dose Module A BMS-791826 Single Ascending Dose Module A Placebo Single Ascending Dose
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution
🇦🇺Melbourne, Victoria, Australia