drugset / Trial / NCT00971724
Biomarkers of Prednisolone Treatment (P05888)
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2006-05
- Primary completion
- 2006-10
- Completion
- 2008-03
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisolone | Other / unclassified | 7.5 mg | Oral |
| Subject | Prednisolone | Other / unclassified | 15 mg | Oral |
| Subject | Prednisolone | Other / unclassified | 30 mg | Oral |
| Subject | Prednisolone | Other / unclassified | 75 mg | Oral |