Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2006-05-31
2008-03-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Treatment with placebo for 15 days
Placebo
Oral administration, once daily, for 15 days
Prednisolone 7.5 mg daily
Treatment with prednisolone 7.5 mg daily for 15 days
Prednisolone
Oral administration
Prednisolone 15 mg daily
Treatment with prednisolone 15 mg daily for 15 days
Prednisolone
Oral administration
Prednisolone 30 mg daily
Treatment with prednisolone 30 mg daily for 15 days
Prednisolone
Oral administration
Prednisolone 75 mg
Treatment with prednisolone 75 mg for a single day
Prednisolone
Oral administration
Prednisolone 15 mg twice daily
Treatment with prednisolone 15 mg twice daily for a single day
Prednisolone
Oral administration
Interventions
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Placebo
Oral administration, once daily, for 15 days
Prednisolone
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
45 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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Ellero-Simatos S, Szymanska E, Rullmann T, Dokter WH, Ramaker R, Berger R, van Iersel TM, Smilde AK, Hankemeier T, Alkema W. Assessing the metabolic effects of prednisolone in healthy volunteers using urine metabolic profiling. Genome Med. 2012 Nov 30;4(11):94. doi: 10.1186/gm395. eCollection 2012.
Toonen EJ, Fleuren WW, Nassander U, van Lierop MJ, Bauerschmidt S, Dokter WH, Alkema W. Prednisolone-induced changes in gene-expression profiles in healthy volunteers. Pharmacogenomics. 2011 Jul;12(7):985-98. doi: 10.2217/pgs.11.34. Epub 2011 Jun 2.
Other Identifiers
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294001
Identifier Type: OTHER
Identifier Source: secondary_id
P05888
Identifier Type: -
Identifier Source: org_study_id
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