NCT00971724CompletedNot 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Placebo Comparator
Treatment with placebo for 15 days
Intervention: Placebo (Drug)
Prednisolone 7.5 mg daily
Experimental
Treatment with prednisolone 7.5 mg daily for 15 days
Intervention: Prednisolone (Drug)
Prednisolone 75 mg
Experimental
Treatment with prednisolone 75 mg for a single day
Intervention: Prednisolone (Drug)
Prednisolone 15 mg daily
Experimental
Treatment with prednisolone 15 mg daily for 15 days
Intervention: Prednisolone (Drug)
Prednisolone 30 mg daily
Experimental
Treatment with prednisolone 30 mg daily for 15 days
Intervention: Prednisolone (Drug)
Prednisolone 15 mg twice daily
Experimental
Treatment with prednisolone 15 mg twice daily for a single day
Intervention: Prednisolone (Drug)
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)
Investigators
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