NCT00971724
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Insulin Resistance
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 72
- Primary Endpoint
- To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Treatment with placebo for 15 days
Intervention: Placebo
Prednisolone 7.5 mg daily
Treatment with prednisolone 7.5 mg daily for 15 days
Intervention: Prednisolone
Prednisolone 75 mg
Treatment with prednisolone 75 mg for a single day
Intervention: Prednisolone
Prednisolone 15 mg daily
Treatment with prednisolone 15 mg daily for 15 days
Intervention: Prednisolone
Prednisolone 30 mg daily
Treatment with prednisolone 30 mg daily for 15 days
Intervention: Prednisolone
Prednisolone 15 mg twice daily
Treatment with prednisolone 15 mg twice daily for a single day
Intervention: Prednisolone
Outcomes
Primary Outcomes
To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
Time Frame: Day 1 and day 15
Secondary Outcomes
- To describe the PK of prednisolone and PD of a series of biomarkers(Day 1 and day 15)
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