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Biomarkers of Prednisolone Treatment (P05888)

Primary Purpose

Insulin Resistance, Hyperglycemia, Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Prednisolone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Prednisolone, Glucocorticoids

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    Prednisolone 7.5 mg daily

    Prednisolone 15 mg daily

    Prednisolone 30 mg daily

    Prednisolone 75 mg

    Prednisolone 15 mg twice daily

    Arm Description

    Treatment with placebo for 15 days

    Treatment with prednisolone 7.5 mg daily for 15 days

    Treatment with prednisolone 15 mg daily for 15 days

    Treatment with prednisolone 30 mg daily for 15 days

    Treatment with prednisolone 75 mg for a single day

    Treatment with prednisolone 15 mg twice daily for a single day

    Outcomes

    Primary Outcome Measures

    To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone

    Secondary Outcome Measures

    To describe the PK of prednisolone and PD of a series of biomarkers

    Full Information

    First Posted
    September 3, 2009
    Last Updated
    May 21, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00971724
    Brief Title
    Biomarkers of Prednisolone Treatment (P05888)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance, Hyperglycemia, Glucose Intolerance
    Keywords
    Prednisolone, Glucocorticoids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Treatment with placebo for 15 days
    Arm Title
    Prednisolone 7.5 mg daily
    Arm Type
    Experimental
    Arm Description
    Treatment with prednisolone 7.5 mg daily for 15 days
    Arm Title
    Prednisolone 15 mg daily
    Arm Type
    Experimental
    Arm Description
    Treatment with prednisolone 15 mg daily for 15 days
    Arm Title
    Prednisolone 30 mg daily
    Arm Type
    Experimental
    Arm Description
    Treatment with prednisolone 30 mg daily for 15 days
    Arm Title
    Prednisolone 75 mg
    Arm Type
    Experimental
    Arm Description
    Treatment with prednisolone 75 mg for a single day
    Arm Title
    Prednisolone 15 mg twice daily
    Arm Type
    Experimental
    Arm Description
    Treatment with prednisolone 15 mg twice daily for a single day
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral administration, once daily, for 15 days
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone
    Intervention Description
    Oral administration
    Primary Outcome Measure Information:
    Title
    To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
    Time Frame
    Day 1 and day 15
    Secondary Outcome Measure Information:
    Title
    To describe the PK of prednisolone and PD of a series of biomarkers
    Time Frame
    Day 1 and day 15

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23199229
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    21635145
    Citation
    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.
    Results Reference
    derived

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    Biomarkers of Prednisolone Treatment (P05888)

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