Status:
COMPLETED
Biomarkers of Prednisolone Treatment (P05888)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Insulin Resistance
Hyperglycemia
Eligibility:
MALE
20-45 years
Phase:
NA
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 prednisolon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00971724
Start Date
May 1 2006
End Date
March 1 2008
Last Update
May 22 2015
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