Biomarkers of Prednisolone Treatment (P05888)

A Randomized, Placebo-controlled, Double-blind, Single-center Study Using Multiple Doses of Prednisolone to Quantify Effects on Selected Biomarkers and Assess Pharmacokinetics in Healthy Males

Primary objective:

• To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.

Secondary objectives:

• To describe the PK of prednisolone and PD of a series of biomarkers.
• To identify biomarkers that reflect side effects of prednisolone.
• To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

Inclusion Criteria:

• 22 < BMI < 30
• fasting glucose < 5.6 mmol/L and glucose < 7.8 mmol/L 2hr after OGTT
• able and willing to sign informed consent
• history of good physical and mental health
• subject smokes less than 5 cigarettes per day
• able to keep a normal day and night rhythm

Exclusion Criteria:

• allergy to prednisolone
• glucocorticoid use during last 3 months prior to study
• use of any drug or substance
• history of familiar diabetes type 2
• clinically relevant history or presence of any medical disorder
• clinically relevant abnormal lab or ECG
• positive drug or alcohol screen, positive hepatitis B or C surface antigen
• donation of blood (>100 mL) within 90 days prior to the first dose