A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

• Status: Completed
• Trial end date: 2009-05-18
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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