Biomarkers of Prednisolone Treatment (P05888)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Insulin Resistance, Hyperglycemia, Glucose Intolerance

Intervention / Treatment
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* Drug: Placebo
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Treatment with placebo for 15 days | Drug: Placebo<br>* Oral administration, once daily, for 15 days<br>|
| Experimental: Prednisolone 7.5 mg daily<br>Treatment with prednisolone 7.5 mg daily for 15 days | Drug: Prednisolone<br>* Oral administration<br>|
| Experimental: Prednisolone 15 mg daily<br>Treatment with prednisolone 15 mg daily for 15 days | Drug: Prednisolone<br>* Oral administration<br>|
| Experimental: Prednisolone 30 mg daily<br>Treatment with prednisolone 30 mg daily for 15 days | Drug: Prednisolone<br>* Oral administration<br>|
| Experimental: Prednisolone 75 mg<br>Treatment with prednisolone 75 mg for a single day | Drug: Prednisolone<br>* Oral administration<br>|
| Experimental: Prednisolone 15 mg twice daily<br>Treatment with prednisolone 15 mg twice daily for a single day | Drug: Prednisolone<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone |  | Day 1 and day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the PK of prednisolone and PD of a series of biomarkers |  | Day 1 and day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prednisolone, Glucocorticoids