Biomarkers of Prednisolone Treatment (P05888)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Resistance; Hyperglycemia; Glucose Intolerance
Intervention: Placebo (Drug); Prednisolone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
Secondary outcome: To describe the PK of prednisolone and PD of a series of biomarkers
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Starting date: May 2006
Last updated: May 21, 2015
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