Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarkers of Prednisolone Treatment (P05888)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00971724
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Hyperglycemia Glucose Intolerance Drug: Placebo Drug: Prednisolone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : March 2008


Arm Intervention/treatment
Placebo Comparator: Placebo
Treatment with placebo for 15 days
Drug: Placebo
Oral administration, once daily, for 15 days

Experimental: Prednisolone 7.5 mg daily
Treatment with prednisolone 7.5 mg daily for 15 days
Drug: Prednisolone
Oral administration

Experimental: Prednisolone 15 mg daily
Treatment with prednisolone 15 mg daily for 15 days
Drug: Prednisolone
Oral administration

Experimental: Prednisolone 30 mg daily
Treatment with prednisolone 30 mg daily for 15 days
Drug: Prednisolone
Oral administration

Experimental: Prednisolone 75 mg
Treatment with prednisolone 75 mg for a single day
Drug: Prednisolone
Oral administration

Experimental: Prednisolone 15 mg twice daily
Treatment with prednisolone 15 mg twice daily for a single day
Drug: Prednisolone
Oral administration




Primary Outcome Measures :
  1. 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 Measures :
  1. To describe the PK of prednisolone and PD of a series of biomarkers [ Time Frame: Day 1 and day 15 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00971724    
Other Study ID Numbers: P05888
294001 ( Other Identifier: Merck )
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Prednisolone
Glucocorticoids
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperglycemia
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents