Biomarkers of Prednisolone Treatment (P05888)

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971724
• Other study ID #: P05888
• Secondary ID: 294001
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: May 21, 2015
• Start date: May 2006
• Est. completion date: March 2008

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2008
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperglycemia
• Insulin Resistance

Intervention

Drug:
• Placebo
Oral administration, once daily, for 15 days
• Prednisolone
Oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone		Day 1 and day 15	No
Secondary	To describe the PK of prednisolone and PD of a series of biomarkers		Day 1 and day 15	No