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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.


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


Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

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