Biomarkers of Prednisolone Treatment (Study 294001)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00971724
First received: September 3, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

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 Intervention
Insulin Resistance
Hyperglycemia
Glucose Intolerance
Drug: Placebo
Drug: Prednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone [ Time Frame: Day 1 and day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the PK of prednisolone and PD of a series of biomarkers [ Time Frame: Day 1 and day 15 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: May 2006
Study Completion Date: March 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00971724     History of Changes
Other Study ID Numbers: 294001
Study First Received: September 3, 2009
Last Updated: November 2, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Schering-Plough:
Prednisolone
Glucocorticoids

Additional relevant MeSH terms:
Hyperglycemia
Insulin Resistance
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014