Trials / Completed
CompletedNCT00971724
Biomarkers of Prednisolone Treatment (P05888)
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Oral administration, once daily, for 15 days |
| DRUG | Prednisolone | Oral administration |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2006-10-01
- Completion
- 2008-03-01
- First posted
- 2009-09-04
- Last updated
- 2015-05-22
Source: ClinicalTrials.gov record NCT00971724. Inclusion in this directory is not an endorsement.